Trial Outcomes & Findings for A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma (NCT NCT05590377)

NCT ID: NCT05590377

Last Updated: 2025-12-19

Results Overview

DLT was defined as any of the treatment-emergent adverse events (TEAEs) that occurred during Cycle 1 and were considered by the investigator to be at least possibly related to modakafusp alfa. Toxicity was evaluated according to national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version 5.0.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: Phase 1: Cycle 1 (cycle length=28 days)
• Results posted on: 2025-12-19

Participant Flow

Participants took part in the study at 9 investigative sites globally from 23 January 2023 to 22 May 2024.

Participants with multiple myeloma were enrolled in Phase 1 (Dose Escalation) to receive modakafusp alfa (80 milligrams [mg], 120 mg or 240 mg) + daratumumab. No participants were enrolled in Phase 2a (Dose Finding) as the study was terminated by the Sponsor due to strategic reasons.

Participant milestones

Measure	Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.	Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Participants were planned to receive modakafusp alfa at dose level 1 (DL1) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.	Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab Participants were planned to receive modakafusp alfa at dose level 2 (DL2) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
Overall Study STARTED	3	6	6	0	0
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	3	6	6	0	0

Reasons for withdrawal

Measure	Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.	Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Participants were planned to receive modakafusp alfa at dose level 1 (DL1) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.	Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab Participants were planned to receive modakafusp alfa at dose level 2 (DL2) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
Overall Study Death	1	1	2	0	0
Overall Study Study Terminated by Sponsor	1	5	4	0	0
Overall Study Withdrawal by Subject	1	0	0	0	0

Baseline Characteristics

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Measure	Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab n=3 Participants Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab n=6 Participants Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab n=6 Participants Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.	Total n=15 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants	4 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Age, Continuous	71.7 years STANDARD_DEVIATION 18.34 • n=8 Participants	63.7 years STANDARD_DEVIATION 11.64 • n=6 Participants	59.2 years STANDARD_DEVIATION 12.02 • n=6 Participants	63.5 years STANDARD_DEVIATION 13.05 • n=9 Participants
Sex: Female, Male Female	2 Participants n=8 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants	6 Participants n=9 Participants
Sex: Female, Male Male	1 Participants n=8 Participants	4 Participants n=6 Participants	4 Participants n=6 Participants	9 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=8 Participants	4 Participants n=6 Participants	3 Participants n=6 Participants	10 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants	4 Participants n=6 Participants	0 Participants n=6 Participants	4 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=8 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	2 Participants n=9 Participants
Race (NIH/OMB) White	3 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	4 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	5 Participants n=9 Participants

PRIMARY outcome

Timeframe: Phase 1: Cycle 1 (cycle length=28 days)

Population: The Dose Limiting Toxicity (DLT)-evaluable Population included all participants from the Phase 1 dose escalation portion who experienced a DLT in Cycle 1 in the treatment phase of the study or had completed the Cycle 1 dose of modakafusp alfa and at least 75% of the planned dose of daratumumab SC.

DLT was defined as any of the treatment-emergent adverse events (TEAEs) that occurred during Cycle 1 and were considered by the investigator to be at least possibly related to modakafusp alfa. Toxicity was evaluated according to national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version 5.0.

Outcome measures

Measure	Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab n=3 Participants Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab n=6 Participants Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab n=6 Participants Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.	Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Participants were planned to receive modakafusp alfa at dose level 1 (DL1) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.	Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab Participants were planned to receive modakafusp alfa at dose level 2 (DL2) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
Phase 1: Number of Participants With Dose Limiting Toxicities (DLT)	0 Participants	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: Phase 1: Up to 15.9 months

Population: The Safety Population included all participants who received at least 1 dose, even an incomplete dose, of any study drug.

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs were evaluated as per the NCI CTCAE Version 5.0.

Outcome measures

Measure	Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab n=3 Participants Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab n=6 Participants Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab n=6 Participants Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.	Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Participants were planned to receive modakafusp alfa at dose level 1 (DL1) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.	Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab Participants were planned to receive modakafusp alfa at dose level 2 (DL2) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
Phase 1: Number of Participants Reporting One or More TEAEs and Per Severity Grade 1	1 Participants	0 Participants	0 Participants	—	—
Phase 1: Number of Participants Reporting One or More TEAEs and Per Severity Grade 4	0 Participants	0 Participants	1 Participants	—	—
Phase 1: Number of Participants Reporting One or More TEAEs and Per Severity Grade 5	0 Participants	0 Participants	1 Participants	—	—
Phase 1: Number of Participants Reporting One or More TEAEs and Per Severity Grade 2	0 Participants	2 Participants	1 Participants	—	—
Phase 1: Number of Participants Reporting One or More TEAEs and Per Severity Grade 3	2 Participants	4 Participants	3 Participants	—	—

PRIMARY outcome

Timeframe: Phase 2a: Up to 15.9 months

Population: After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons. Thus, no participants were enrolled for Phase 2a and no data was collected for this outcome measure due to study termination.

ORR is defined as the percentage of participants who achieve a confirmed partial response (PR) or better during the study in the safety population. ORR will be assessed by the investigator per International Myeloma Working Group (IMWG) criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 1: Up to 15.9 months

Population: The Response-evaluable Population included all participants who received at least 1 dose, even an incomplete dose, of any study drug, have a disease assessment at screening (baseline evaluation), and at least 1 postbaseline disease assessment.

ORR is defined as the percentage of participants who achieved a confirmed PR or better during the study in the safety population. ORR will be assessed by the investigator per IMWG criteria.

Outcome measures

Measure	Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab n=3 Participants Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab n=6 Participants Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab n=6 Participants Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.	Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Participants were planned to receive modakafusp alfa at dose level 1 (DL1) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.	Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab Participants were planned to receive modakafusp alfa at dose level 2 (DL2) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
Phase 1: Overall Response Rate (ORR)	33.3 percentage of participants Interval 0.84 to 90.57	66.7 percentage of participants Interval 22.28 to 95.67	50.0 percentage of participants Interval 11.81 to 88.19	—	—

SECONDARY outcome

Timeframe: Up to 15.9 months

DOR is defined as the time from the date of first documentation of a confirmed PR or better to the date of first documentation of confirmed progressive disease or death due to any cause, whichever occurs first. DOR will be calculated for confirmed responders only (PR or better). DOR will be assessed by the investigator as per IMWG criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 15.9 months

PFS is defined as the time from the date of the first dose administration of any study drug to the first documentation of confirmed progressive disease or death due to any cause, whichever occurs first. PFS will be assessed by the investigator as per IMWG criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 15.9 months

OS is defined as the time from the date of the first dose administration of any study drug to the documentation of death due to any cause. OS will be assessed by the investigator as per IMWG criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 15.9 months

Population: Immunogenicity-evaluable Population included participants who received at least 1 dose of modakafusp alfa in combination with daratumumab SC (partial or complete) with a baseline assessment \& at least 1 postbaseline immunogenicity assessment. No data was collected for this outcome measure due to study termination. Overall number of participants analyzed is the number of participants with data available for analyses.

After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons and hence no participants were enrolled for Phase 2a.

Outcome measures

Measure	Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab n=3 Participants Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab n=6 Participants Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.	Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Participants were planned to receive modakafusp alfa at dose level 1 (DL1) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.	Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab Participants were planned to receive modakafusp alfa at dose level 2 (DL2) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
Phase 1 and Phase 2a: Number of Participants With Anti-drug Antibodies (ADA)	3 Participants	2 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 15.9 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 15.9 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 15.9 months

Population: Only participants who had a confirmed stringent CR (sCR) or complete response (CR) were to be analyzed for this outcome measure. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons. Thus, no participants were enrolled for Phase 2a \& no data was collected for this outcome measure due to study termination.

MRD[-] CR rate is defined as the percentage of participants who achieve confirmed CR assessed by the investigator and MRD[-] status using a threshold of 10^-5. The analysis will be based on the response-evaluable population. No participants had sCR or CR in Phase 1 thus the overall number of participants analyzed is zero.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 15.9 months

Population: Only participants who had a confirmed stringent CR (sCR) or complete response (CR) were to be analyzed for this outcome measure. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons. Thus, no participants were enrolled for Phase 2a \& no data was collected for this outcome measure due to study termination.

Duration of MRD negativity for participants achieving MRD negativity is defined as the time from the date of first documentation of MRD negativity to the first documentation of MRD positivity or confirmed progressive disease, whichever occurs first. It will be calculated for participants achieving MRD negativity only. No participants had sCR or CR in Phase 1 thus the overall number of participants analyzed is zero.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 2a: Up to 15.9 months

Population: After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons. Thus, no participants were enrolled for Phase 2a \& no data was collected for this outcome measure due to study termination.

CBR is defined as the percentage of participants who had a confirmed response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response based on investigators' disease assessment per IMWG criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 2a: Up to 15.9 months

Population: After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a \& no data was collected for this outcome measure due to study termination.

DCB is defined as the time from the date of first documentation of a minimal response or better to the date of first documentation of confirmed progressive disease or death due to any cause, whichever occurs first. DCB will be calculated for only participants who achieved a minimal response or better. DCB will be assessed by the investigator as per IMWG criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 2a: Up to 15.9 months

Population: After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a \& no data was collected for this outcome measure due to study termination.

DCR is defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, minimal response, or stable disease (SD) based on investigators' disease assessment per IMWG criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 2a: Up to 15.9 months

Population: After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a \& no data was collected for this outcome measure due to study termination.

Duration of disease control is defined as the time from date of first documentation of SD or better to the date of first documentation of confirmed progressive disease or death due to any cause. Duration of disease control will be calculated for only patients who achieved SD or better. It will be assessed by the investigator per IMWG criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 2a: Up to 15.9 months

Population: After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a \& no data was collected for this outcome measure due to study termination.

TTP is defined as the time from the date of randomization to the first documentation of confirmed progressive disease as defined by IMWG criteria, assessed by the investigator. Participants without documentation of confirmed progression will be censored at the date of last adequate disease assessment. The analysis will be based on the intent-to-treat (ITT) population.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 2a: Up to 15.9 months

Population: After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a \& no data was collected for this outcome measure due to study termination.

TTR is defined as time from the date of first dose administration of any study drug to the date of the first documentation of a confirmed PR or better. TTR will be calculated for responders only. TTR will be assessed by the investigator per IMWG criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 2a: Up to 15.9 months

Population: After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a \& no data was collected for this outcome measure due to study termination.

TTNT is defined as the time from the date of first dose administration of any study drug to the date of the first dose initiation of the next line of anticancer therapy for any reason or death from any cause, whichever comes first. Participants who have not started the next-line therapy will be censored at the date last known to be alive before subsequent anticancer therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase 2a: Up to 15.9 months

Population: After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a \& no data was collected for this outcome measure due to study termination.

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs will be evaluated as per the NCI CTCAE Version 5.0.

Outcome measures

Outcome data not reported

Adverse Events

Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab

Serious events: 2 serious events

Other events: 6 other events

Deaths: 2 deaths

Serious adverse events

Measure	Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab n=3 participants at risk Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab n=6 participants at risk Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab n=6 participants at risk Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.
Psychiatric disorders Confusional state	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
General disorders General physical health deterioration	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
General disorders Hyperthermia	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.

Other adverse events

Measure	Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab n=3 participants at risk Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab n=6 participants at risk Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.	Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab n=6 participants at risk Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.
Gastrointestinal disorders Abdominal discomfort	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	66.7% 4/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Psychiatric disorders Anxiety	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
General disorders Asthenia	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Cardiac disorders Atrial fibrillation	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Musculoskeletal and connective tissue disorders Back pain	100.0% 3/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Investigations Blood lactate dehydrogenase increased	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Investigations Blood pressure systolic increased	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Investigations Blood triglycerides increased	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
General disorders Chills	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	33.3% 2/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Gastrointestinal disorders Constipation	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	33.3% 2/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Eye disorders Dry eye	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Gastrointestinal disorders Dry mouth	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Nervous system disorders Dysgeusia	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Respiratory, thoracic and mediastinal disorders Dyspnoea	66.7% 2/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Injury, poisoning and procedural complications Fall	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
General disorders Fatigue	100.0% 3/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	33.3% 2/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Renal and urinary disorders Haematuria	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Investigations Haemoglobin decreased	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Nervous system disorders Headache	66.7% 2/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Investigations Heart rate increased	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Metabolism and nutrition disorders Hypercalcaemia	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Metabolism and nutrition disorders Hypercreatininaemia	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Metabolism and nutrition disorders Hyperphagia	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Metabolism and nutrition disorders Hyperphosphataemia	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Endocrine disorders Hypogonadism	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
General disorders Pain	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Injury, poisoning and procedural complications Infusion related reaction	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
General disorders Injection site erythema	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Psychiatric disorders Insomnia	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	33.3% 2/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Eye disorders Lacrimation increased	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Musculoskeletal and connective tissue disorders Muscular weakness	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Gastrointestinal disorders Nausea	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Nervous system disorders Nervous system disorder	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	50.0% 3/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	66.7% 4/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
General disorders Non-cardiac chest pain	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Eye disorders Ocular hyperaemia	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
General disorders Pyrexia	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	33.3% 2/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Infections and infestations Rash pustular	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Cardiac disorders Tachycardia	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Blood and lymphatic system disorders Thrombocytopenia	66.7% 2/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	50.0% 3/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	66.7% 4/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Gastrointestinal disorders Toothache	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	16.7% 1/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	33.3% 2/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Renal and urinary disorders Urinary incontinence	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Eye disorders Vision blurred	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.
Investigations Weight decreased	33.3% 1/3 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.	0.00% 0/6 • Phase 1: Up to 15.9 months The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled \& no adverse events were reported for Phase 2a.

Additional Information

Study Director

Takeda (Note: This product was divested to Teva Pharmaceuticals in 2025)

Phone: +1-877-825-3327

Email: TrialDisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60