Trial Outcomes & Findings for Study to Evaluate the AIO-001 in Healthy Participants (NCT NCT06170827)
NCT ID: NCT06170827
Last Updated: 2025-08-14
Results Overview
An AE was defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs were defined as AEs that commence on or after the time of study drug administration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
From Day 1 up to Day 169
Results posted on
2025-08-14
Participant Flow
Participant milestones
| Measure |
AIO-001: Formulation A
Participants received 400 milligrams (mg) of 100 milligrams per milliliter (mg/ml) AIO-001, administered as 4\*1.0 milliliter (ml) subcutaneous (SC) injection on Day 1.
|
AIO-001: Formulation B
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
AIO-001: Formulation A
Participants received 400 milligrams (mg) of 100 milligrams per milliliter (mg/ml) AIO-001, administered as 4\*1.0 milliliter (ml) subcutaneous (SC) injection on Day 1.
|
AIO-001: Formulation B
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Study to Evaluate the AIO-001 in Healthy Participants
Baseline characteristics by cohort
| Measure |
AIO-001: Formulation A
n=8 Participants
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=8 Participants
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 7.45 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 10.48 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 8.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 169Population: The safety population included all participants who received at least one dose of the study drug.
An AE was defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs were defined as AEs that commence on or after the time of study drug administration.
Outcome measures
| Measure |
AIO-001: Formulation A
n=8 Participants
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=8 Participants
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1) up to Day 169Population: The safety population included all participants who received at least one dose of the study drug.
Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature measurements. The clinically significant changes were based on investigator's judgement.
Outcome measures
| Measure |
AIO-001: Formulation A
n=8 Participants
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=8 Participants
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1) up to Day 169Population: The safety population included all participants who received at least one dose of the study drug.
The electrocardiogram parameters included heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval and QRS. The clinically significant changes were based on investigator's judgement.
Outcome measures
| Measure |
AIO-001: Formulation A
n=8 Participants
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=8 Participants
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram Parameters
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1) up to Day 169Population: The safety population included all participants who received at least one dose of the study drug.
Physical examination included assessments of the following: head, eyes, ears, nose, throat, neck, chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral vascular, and general neurological examination. The clinically significant changes were based on investigator's judgement.
Outcome measures
| Measure |
AIO-001: Formulation A
n=8 Participants
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=8 Participants
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Physical Examination Findings
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1) up to Day 169Population: The safety population included all participants who received at least one dose of the study drug.
Clinical laboratory parameters included biochemistry, hematology, and urinalysis assessment. The clinically significant changes were based on investigator's judgement.
Outcome measures
| Measure |
AIO-001: Formulation A
n=8 Participants
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=8 Participants
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dosePopulation: The PK population included all participants who had at least 1 measured PK concentration following dosing. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
AIO-001: Formulation A
n=7 Participants
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=7 Participants
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-last) of AIO-001
|
4608.31 day*microgram per milliliter(day*mcg/mL)
Geometric Coefficient of Variation 30.04
|
4935.31 day*microgram per milliliter(day*mcg/mL)
Geometric Coefficient of Variation 18.18
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dosePopulation: The PK population included all participants who had at least 1 measured PK concentration following dosing. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. The residual area was greater than 20% in 15 out of the total of 16 participants and therefore the estimation of AUC0-inf may be non-identifiable.
Outcome measures
| Measure |
AIO-001: Formulation A
n=7 Participants
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=8 Participants
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AIO-001
|
7092.12 day*mcg/mL
Geometric Coefficient of Variation 30.49
|
8088.05 day*mcg/mL
Geometric Coefficient of Variation 22.92
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dosePopulation: The PK population included all participants who had at least 1 measured PK concentration following dosing.
Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
AIO-001: Formulation A
n=8 Participants
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=8 Participants
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Maximal Observed Concentration (Cmax) of AIO-001
|
43.69 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 35.83
|
47.49 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 22.22
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dosePopulation: The PK population included all participants who had at least 1 measured PK concentration following dosing.
Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
AIO-001: Formulation A
n=8 Participants
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=8 Participants
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Time to Maximal Observed Concentration (Tmax) of AIO-001
|
13.55 day
Interval 7.94 to 21.97
|
17.43 day
Interval 4.0 to 27.16
|
SECONDARY outcome
Timeframe: Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dosePopulation: The PK population included all participants who had at least 1 measured PK concentration following dosing. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. The residual area was greater than 20% in 15 out of the total of 16 participants and therefore the estimation of T½ may be non-identifiable.
Outcome measures
| Measure |
AIO-001: Formulation A
n=7 Participants
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=8 Participants
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Terminal Elimination Half-life (T½) of AIO-001
|
104.34 day
Standard Deviation 24.11
|
119.35 day
Standard Deviation 45.20
|
SECONDARY outcome
Timeframe: Up to Day 169Population: The immunogenicity population included all participants who received any amount of AIO-001 and had at least one post-dose ADA measurement.
ADA-positive participant was defined as participant with at least one treatment-induced or treatment-boosted ADA-positive sample at any time during the treatment or follow-up observation period. Anti-AIO-001 antibodies were evaluated in serum samples. Serum samples were screened for antibodies binding to AIO-001.
Outcome measures
| Measure |
AIO-001: Formulation A
n=8 Participants
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=8 Participants
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Positive Anti-drug Antibody (ADA) to AIO-001
|
0 Participants
|
4 Participants
|
Adverse Events
AIO-001: Formulation A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AIO-001: Formulation B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AIO-001: Formulation A
n=8 participants at risk
Participants received 400 mg of 100 mg/ml AIO-001, administered as 4\*1.0 ml SC injection on Day 1.
|
AIO-001: Formulation B
n=8 participants at risk
Participants received 400 mg of 182 mg/ml AIO-001, administered as 2\*1.1 ml SC injection on Day 1.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Wound infection
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Investigations
Troponin I increased
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myokymia
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place