Trial Outcomes & Findings for Safety and Efficacy of CIS43LS Anti-malaria mAb in Mali (NCT NCT04329104)
NCT ID: NCT04329104
Last Updated: 2025-04-09
Results Overview
Participants with incidence of local adverse events occurring within 7 days after administration of CIS43LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
348 participants
Primary outcome timeframe
Within 7 days after administration of CIS43LS
Results posted on
2025-04-09
Participant Flow
Participant milestones
| Measure |
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 3: Placebo
Participants receive placebo as one time intravenous infusion on Day 0.
|
|---|---|---|---|---|---|---|
|
Dose Escalation Study - 5 mg/kg
STARTED
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Study - 5 mg/kg
COMPLETED
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Study - 5 mg/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Study - 10 mg/kg
STARTED
|
0
|
6
|
0
|
0
|
0
|
0
|
|
Dose Escalation Study - 10 mg/kg
COMPLETED
|
0
|
6
|
0
|
0
|
0
|
0
|
|
Dose Escalation Study - 10 mg/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Study - 40 mg/kg
STARTED
|
0
|
0
|
6
|
0
|
0
|
0
|
|
Dose Escalation Study - 40 mg/kg
COMPLETED
|
0
|
0
|
6
|
0
|
0
|
0
|
|
Dose Escalation Study - 40 mg/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Efficacy Study
STARTED
|
0
|
0
|
0
|
110
|
110
|
110
|
|
Efficacy Study
COMPLETED
|
0
|
0
|
0
|
105
|
104
|
102
|
|
Efficacy Study
NOT COMPLETED
|
0
|
0
|
0
|
5
|
6
|
8
|
Reasons for withdrawal
| Measure |
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 3: Placebo
Participants receive placebo as one time intravenous infusion on Day 0.
|
|---|---|---|---|---|---|---|
|
Efficacy Study
Withdrawal by Subject
|
0
|
0
|
0
|
5
|
6
|
8
|
Baseline Characteristics
Safety and Efficacy of CIS43LS Anti-malaria mAb in Mali
Baseline characteristics by cohort
| Measure |
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
n=6 Participants
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
n=6 Participants
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
n=6 Participants
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
n=110 Participants
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
n=110 Participants
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 3: Placebo
n=110 Participants
Participants receive placebo as one time intravenous infusion on Day 0.
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
18-20 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Age, Customized
21-30 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
93 Participants
n=8 Participants
|
|
Age, Customized
31-40 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
119 Participants
n=8 Participants
|
|
Age, Customized
41-50 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
93 Participants
n=8 Participants
|
|
Age, Customized
51-55 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
149 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
66 Participants
n=8 Participants
|
199 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
110 Participants
n=8 Participants
|
348 Participants
n=8 Participants
|
|
Region of Enrollment
Mali
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
110 Participants
n=8 Participants
|
348 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after administration of CIS43LSPopulation: The analysis included all participants in the dose escalation study.
Participants with incidence of local adverse events occurring within 7 days after administration of CIS43LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion.
Outcome measures
| Measure |
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
n=6 Participants
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
n=6 Participants
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
n=6 Participants
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
|---|---|---|---|---|---|
|
Participants With Local Adverse Events (AEs)
Injection site swelling
|
0 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Participants With Local Adverse Events (AEs)
Pain at injection site
|
0 Participants
|
—
|
—
|
2 Participants
|
2 Participants
|
|
Participants With Local Adverse Events (AEs)
Tenderness at injection site
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Participants With Local Adverse Events (AEs)
Redness at injection site
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Participants With Local Adverse Events (AEs)
Bruising at injection site
|
0 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Participants With Local Adverse Events (AEs)
Pruritus at injection site
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after the administration of CIS43LSPopulation: The analysis included all participants in the dose escalation study.
The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials. Grade 1: Pain = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity. Grade 2: Pain = Repeated use of non-narcotic pain reliever \> 24 hours or interferes with daily activity; Tenderness = Discomfort with movement; Erythema/Redness = 5.1-10 cm; Induration/Swelling = 5.1-10 cm and interferes with activity. Grade 3: Pain = Any use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = \> 10 cm; Induration/Swelling = \> 10 cm or prevents daily activity. Grade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; Induration/Swelling = Necrosis Grade 5: Death
Outcome measures
| Measure |
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
n=6 Participants
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
n=6 Participants
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
n=6 Participants
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
|---|---|---|---|---|---|
|
Severity of Local Adverse Events (AEs)
Grade 1
|
0 Participants
|
—
|
—
|
4 Participants
|
2 Participants
|
|
Severity of Local Adverse Events (AEs)
Grade 2
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Severity of Local Adverse Events (AEs)
Grade 3
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Severity of Local Adverse Events (AEs)
Grade 4
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Severity of Local Adverse Events (AEs)
Grade 5
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after the administration of CIS43LSPopulation: The analysis included all participants in the dose escalation study.
Participants with incidence of systemic adverse events occurring within 7 days after product administration of CIS43LS. Systemic reactogenicity events included fever, feeling unusually tired or unwell, muscle aches, headache, chills, nausea, and joint pain.
Outcome measures
| Measure |
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
n=6 Participants
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
n=6 Participants
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
n=6 Participants
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
|---|---|---|---|---|---|
|
Participants With Systemic Adverse Events (AEs)
Headache
|
0 Participants
|
—
|
—
|
1 Participants
|
1 Participants
|
|
Participants With Systemic Adverse Events (AEs)
Chills
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Participants With Systemic Adverse Events (AEs)
Fever
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Participants With Systemic Adverse Events (AEs)
Feeling unusually tired or unwell
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Participants With Systemic Adverse Events (AEs)
Muscle aches
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Participants With Systemic Adverse Events (AEs)
Nausea
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Participants With Systemic Adverse Events (AEs)
Joint pain
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after the administration of CIS43LSPopulation: The analysis included all participants in the dose escalation study.
The severity of systemic AEs occurring after the administration of CIS43LS was assessed using the grading scale below: Grade 1: Fever = 37.5\^oC-37.9\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38\^oC-38.4\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \> 24 hours or some interference with activity; Nausea = Some interference with activity or \> 2 episodes/24 hours Grade 3: Fever = 38.5\^oC-39.5\^oC; Fatigue = Prevents daily activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration Grade 4: Fever = \> 39.5\^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock Grade 5: Death
Outcome measures
| Measure |
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
n=6 Participants
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
n=6 Participants
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
n=6 Participants
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
|---|---|---|---|---|---|
|
Severity of Systemic Adverse Events (AEs)
Grade 1
|
0 Participants
|
—
|
—
|
1 Participants
|
1 Participants
|
|
Severity of Systemic Adverse Events (AEs)
Grade 2
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Severity of Systemic Adverse Events (AEs)
Grade 3
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Severity of Systemic Adverse Events (AEs)
Grade 4
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Severity of Systemic Adverse Events (AEs)
Grade 5
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 7 through week 24 (168 days) after administration of interventionPopulation: The analysis included all participants in the efficacy study.
Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by microscopic examination of thick blood smear collected from participants from day 7 through week 24 (168 days) after administration of CIS43LS or placebo. Sample was collected every two weeks until week 24.
Outcome measures
| Measure |
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
n=110 Participants
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
n=110 Participants
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
n=110 Participants
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
|---|---|---|---|---|---|
|
Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination
|
86 Participants
|
—
|
—
|
39 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 21 through week 24 (168 days) after administration of interventionPopulation: The analysis included all participants in the efficacy study.
Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by reverse transcription polymerase chain reaction (RT-PCR) using dried blood spot specimen collected from participants from day 21 through week 24 (168 days) after administration of CIS43LS or placebo. Sample was collected every two weeks until 24 weeks. Plasmodium 18S rRNA RT-PCR assay was applied to dried blood spots during analysis.
Outcome measures
| Measure |
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
n=110 Participants
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
n=110 Participants
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
n=110 Participants
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
|---|---|---|---|---|---|
|
Participants With Plasmodium Falciparum (Pf) Infection Detected by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
|
96 Participants
|
—
|
—
|
48 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Measured through Week 24Population: All participants who received CIS43LS, excluding placebo group.
Maximum serum concentration (Cmax) of CIS43LS by dose group following a single intravenous administration to assess durability of CIS43LS and allow for correlation with Plasmodium falciparum (Pf) infection risk. Cmax is the peak serum concentration that CIS43LS achieves after it has been administered. It is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group and measured by a Meso Scale Discovery LLC-based automation platform.
Outcome measures
| Measure |
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
n=6 Participants
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
n=110 Participants
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
n=109 Participants
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
n=6 Participants
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
n=6 Participants
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) for CIS43LS
|
897.21 µg/mL
Standard Deviation 105.41
|
239.62 µg/mL
Standard Deviation 62.77
|
1033.63 µg/mL
Standard Deviation 286.52
|
120.98 µg/mL
Standard Deviation 22.41
|
280.52 µg/mL
Standard Deviation 40.56
|
SECONDARY outcome
Timeframe: One to 24 hours post-infusionPopulation: All participants who received CIS43LS, excluding placebo group.
Time to maximum total serum concentration (Cmax) of CIS43LS by dose group following a single intravenous administration. Tmax is the time it takes to reach Cmax of CIS43LS after it has been administered; it is determined based on the summary PK curve for each dose group. This was calculated by subtracting the time the CIS43LS intravenous infusion was stopped from the time the blood was collected for the Cmax, at the post-one hour blood draw.
Outcome measures
| Measure |
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
n=6 Participants
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
n=110 Participants
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
n=109 Participants
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
n=6 Participants
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
n=6 Participants
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
|---|---|---|---|---|---|
|
Time to Maximum Serum Concentration (Tmax) for CIS43LS
|
0.583 Hours
Standard Deviation 0.033
|
1.954 Hours
Standard Deviation 5.390
|
0.597 Hours
Standard Deviation 0.115
|
0.561 Hours
Standard Deviation 0.040
|
0.556 Hours
Standard Deviation 0.054
|
Adverse Events
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
Serious events: 1 serious events
Other events: 49 other events
Deaths: 1 deaths
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Efficacy Study: Arm 3: Placebo
Serious events: 2 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
n=6 participants at risk
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
n=6 participants at risk
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
n=6 participants at risk
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
n=110 participants at risk
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
n=110 participants at risk
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 3: Placebo
n=110 participants at risk
Participants receive placebo as one time intravenous infusion on Day 0.
|
|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Appendectomy
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Surgical and medical procedures
Inguinal Hernia Repair
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Surgical and medical procedures
Umbilical Hernia Repair
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Blood and lymphatic system disorders
Hypersplenism
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
Other adverse events
| Measure |
Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS
n=6 participants at risk
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS
n=6 participants at risk
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS
n=6 participants at risk
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 1: 10 mg/kg of CIS43LS
n=110 participants at risk
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 2: 40 mg/kg of CIS43LS
n=110 participants at risk
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
|
Efficacy Study: Arm 3: Placebo
n=110 participants at risk
Participants receive placebo as one time intravenous infusion on Day 0.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Up to 24 weeks
|
33.3%
2/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
6.4%
7/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
9.1%
10/110 • Up to 24 weeks
|
15.5%
17/110 • Up to 24 weeks
|
10.9%
12/110 • Up to 24 weeks
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
10.9%
12/110 • Up to 24 weeks
|
10.9%
12/110 • Up to 24 weeks
|
17.3%
19/110 • Up to 24 weeks
|
|
Eye disorders
Eye Swelling
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
2.7%
3/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
2.7%
3/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
33.3%
2/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
4.5%
5/110 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Dental Caries
|
33.3%
2/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
10.0%
11/110 • Up to 24 weeks
|
7.3%
8/110 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gastric Disorder
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
2/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
12.7%
14/110 • Up to 24 weeks
|
9.1%
10/110 • Up to 24 weeks
|
18.2%
20/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gingival Ulceration
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
2.7%
3/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Strangulated Umbilical Hernia
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
4.5%
5/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
General disorders
Asthenia
|
16.7%
1/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
33.3%
2/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
General disorders
Chest Discomfort
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
General disorders
Chest Pain
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
|
General disorders
Chills
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
7.3%
8/110 • Up to 24 weeks
|
8.2%
9/110 • Up to 24 weeks
|
10.9%
12/110 • Up to 24 weeks
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
General disorders
Hernia Pain
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
33.3%
2/6 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
7.3%
8/110 • Up to 24 weeks
|
10.0%
11/110 • Up to 24 weeks
|
|
General disorders
Swelling
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Up to 24 weeks
|
33.3%
2/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
|
Infections and infestations
Dysentery
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Infections and infestations
Furuncle
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
2.7%
3/110 • Up to 24 weeks
|
4.5%
5/110 • Up to 24 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Infections and infestations
Genital Infection
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
4.5%
5/110 • Up to 24 weeks
|
2.7%
3/110 • Up to 24 weeks
|
|
Infections and infestations
Genitourinary Tract Infection
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Infections and infestations
Herpes Dermatitis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Infections and infestations
Laryngitis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Infections and infestations
Localised Infection
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Infections and infestations
Malaria
|
50.0%
3/6 • Up to 24 weeks
|
33.3%
2/6 • Up to 24 weeks
|
33.3%
2/6 • Up to 24 weeks
|
23.6%
26/110 • Up to 24 weeks
|
14.5%
16/110 • Up to 24 weeks
|
55.5%
61/110 • Up to 24 weeks
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
|
Infections and infestations
Rhinitis
|
66.7%
4/6 • Up to 24 weeks
|
83.3%
5/6 • Up to 24 weeks
|
66.7%
4/6 • Up to 24 weeks
|
16.4%
18/110 • Up to 24 weeks
|
16.4%
18/110 • Up to 24 weeks
|
16.4%
18/110 • Up to 24 weeks
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
|
Infections and infestations
Sinobronchitis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Infections and infestations
Tinea Pedis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Infections and infestations
Tinea Versicolour
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Infections and infestations
Typhus
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
16.7%
1/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Infections and infestations
Wound Infection
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Investigations
Blood Pressure Diastolic Decreased
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
|
Investigations
Blood Pressure Diastolic Increased
|
16.7%
1/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
7.3%
8/110 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
10.9%
12/110 • Up to 24 weeks
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Investigations
Blood Pressure Systolic Decreased
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
2.7%
3/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Investigations
Blood Pressure Systolic Increased
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
4.5%
5/110 • Up to 24 weeks
|
7.3%
8/110 • Up to 24 weeks
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
6.4%
7/110 • Up to 24 weeks
|
9.1%
10/110 • Up to 24 weeks
|
7.3%
8/110 • Up to 24 weeks
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
2.7%
3/110 • Up to 24 weeks
|
2.7%
3/110 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
2.7%
3/110 • Up to 24 weeks
|
2.7%
3/110 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
4.5%
5/110 • Up to 24 weeks
|
6.4%
7/110 • Up to 24 weeks
|
4.5%
5/110 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
8.2%
9/110 • Up to 24 weeks
|
5.5%
6/110 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Up to 24 weeks
|
66.7%
4/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
9.1%
10/110 • Up to 24 weeks
|
7.3%
8/110 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
6.4%
7/110 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
7.3%
8/110 • Up to 24 weeks
|
|
Nervous system disorders
Head Discomfort
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Up to 24 weeks
|
83.3%
5/6 • Up to 24 weeks
|
66.7%
4/6 • Up to 24 weeks
|
40.9%
45/110 • Up to 24 weeks
|
36.4%
40/110 • Up to 24 weeks
|
46.4%
51/110 • Up to 24 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
8.2%
9/110 • Up to 24 weeks
|
10.0%
11/110 • Up to 24 weeks
|
12.7%
14/110 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
2.7%
3/110 • Up to 24 weeks
|
2.7%
3/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
66.7%
4/6 • Up to 24 weeks
|
50.0%
3/6 • Up to 24 weeks
|
50.0%
3/6 • Up to 24 weeks
|
44.5%
49/110 • Up to 24 weeks
|
22.7%
25/110 • Up to 24 weeks
|
29.1%
32/110 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
3.6%
4/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Surgical and medical procedures
Tooth Extraction
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Surgical and medical procedures
Venipuncture
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Up to 24 weeks
|
16.7%
1/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
1.8%
2/110 • Up to 24 weeks
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/6 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
0.91%
1/110 • Up to 24 weeks
|
0.00%
0/110 • Up to 24 weeks
|
Additional Information
Dr. Peter Crompton
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 301-761-5042
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place