Trial Outcomes & Findings for Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab) (NCT NCT06331884)
NCT ID: NCT06331884
Last Updated: 2025-08-06
Results Overview
Number of adverse events (AEs)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
28 days
Results posted on
2025-08-06
Participant Flow
Participant milestones
| Measure |
Placebo
Single intravenous infusion of placebo (vehicle solution matching AK1967) over a 2-hour period
|
AK1967 3 mg/kg/Body Weight
Single intravenous infusion of AK1967 (Procizumab) at a dose of 3 mg/kg over a 2-hour period
|
AK1967 6 mg/kg/Body Weight
Single intravenous infusion of AK1967 (Procizumab) at a dose of 6 mg/kg over a 2-hour period
|
AK1967 12 mg/kg/Body Weight
Single intravenous infusion of AK1967 (Procizumab) at a dose of 12 mg/kg over a 2-hour period
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Single intravenous infusion of placebo (vehicle solution matching AK1967) over a 2-hour period
|
AK1967 3 mg/kg/Body Weight
n=6 Participants
Single intravenous infusion of AK1967 (Procizumab) at a dose of 3 mg/kg over a 2-hour period
|
AK1967 6 mg/kg/Body Weight
n=6 Participants
Single intravenous infusion of AK1967 (Procizumab) at a dose of 6 mg/kg over a 2-hour period
|
AK1967 12 mg/kg/Body Weight
n=6 Participants
Single intravenous infusion of AK1967 (Procizumab) at a dose of 12 mg/kg over a 2-hour period
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 28 daysNumber of adverse events (AEs)
Outcome measures
| Measure |
Placebo
n=6 Participants
Single intravenous infusion of placebo (vehicle solution matching AK1967) over a 2-hour period
|
AK1967 3 mg/kg/Body Weight
n=6 Participants
Single intravenous infusion of AK1967 (Procizumab) at a dose of 3 mg/kg over a 2-hour period
|
AK1967 6 mg/kg/Body Weight
n=6 Participants
Single intravenous infusion of AK1967 (Procizumab) at a dose of 6 mg/kg over a 2-hour period
|
AK1967 12 mg/kg/Body Weight
n=6 Participants
Single intravenous infusion of AK1967 (Procizumab) at a dose of 12 mg/kg over a 2-hour period
|
|---|---|---|---|---|
|
Safety and Tolerability
|
7 AEs
|
8 AEs
|
12 AEs
|
3 AEs
|
SECONDARY outcome
Timeframe: 28-daysPopulation: PK measurements were done in all arms, however for the participants from the placebo group, the measurement results was below the "Lower Limit of Quantification".
Pharmacokinetics of AK1967 - t1/2 (Half life)
Outcome measures
| Measure |
Placebo
n=6 Participants
Single intravenous infusion of placebo (vehicle solution matching AK1967) over a 2-hour period
|
AK1967 3 mg/kg/Body Weight
n=6 Participants
Single intravenous infusion of AK1967 (Procizumab) at a dose of 3 mg/kg over a 2-hour period
|
AK1967 6 mg/kg/Body Weight
n=6 Participants
Single intravenous infusion of AK1967 (Procizumab) at a dose of 6 mg/kg over a 2-hour period
|
AK1967 12 mg/kg/Body Weight
n=6 Participants
Single intravenous infusion of AK1967 (Procizumab) at a dose of 12 mg/kg over a 2-hour period
|
|---|---|---|---|---|
|
Pharmacokinetics of AK1967 - t1/2
|
NA h
Standard Deviation NA
Measurement results was below Lower Limit of Quantification
|
24.3 h
Standard Deviation 2.81
|
34.3 h
Standard Deviation 16.6
|
53.1 h
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: 28 daysPopulation: PK measurements were done in all arms, however for the participants from the placebo group, the measurement results was below the "Lower Limit of Quantification".
Pharmacokinetics of AK1967 - Area Under the Curve
Outcome measures
| Measure |
Placebo
n=6 Participants
Single intravenous infusion of placebo (vehicle solution matching AK1967) over a 2-hour period
|
AK1967 3 mg/kg/Body Weight
n=6 Participants
Single intravenous infusion of AK1967 (Procizumab) at a dose of 3 mg/kg over a 2-hour period
|
AK1967 6 mg/kg/Body Weight
n=6 Participants
Single intravenous infusion of AK1967 (Procizumab) at a dose of 6 mg/kg over a 2-hour period
|
AK1967 12 mg/kg/Body Weight
n=6 Participants
Single intravenous infusion of AK1967 (Procizumab) at a dose of 12 mg/kg over a 2-hour period
|
|---|---|---|---|---|
|
Pharmacokinetics of AK1967 - AUC
|
NA µg*h/ml
Standard Deviation NA
Measurement results was below Lower Limit of Quantification
|
345 µg*h/ml
Standard Deviation 67.9
|
845 µg*h/ml
Standard Deviation 336
|
2076 µg*h/ml
Standard Deviation 584
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AK1967 3 mg/kg/Body Weight
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AK1967 6 mg/kg/Body Weight
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AK1967 12 mg/kg/Body Weight
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Single intravenous infusion of placebo (vehicle solution matching AK1967) over a 2-hour period
|
AK1967 3 mg/kg/Body Weight
n=6 participants at risk
Single intravenous infusion of AK1967 (Procizumab) at a dose of 3 mg/kg over a 2-hour period
|
AK1967 6 mg/kg/Body Weight
n=6 participants at risk
Single intravenous infusion of AK1967 (Procizumab) at a dose of 6 mg/kg over a 2-hour period
|
AK1967 12 mg/kg/Body Weight
n=6 participants at risk
Single intravenous infusion of AK1967 (Procizumab) at a dose of 12 mg/kg over a 2-hour period
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sore throat and nasal congestion
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Musculoskeletal and connective tissue disorders
Headache and neckpain
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
General disorders
headache, combined with symptoms of exhaustion
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Musculoskeletal and connective tissue disorders
Episodic stinging pain around the left collarbone
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Respiratory, thoracic and mediastinal disorders
Tonsilitis accompanied by a fever and fatigue
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Musculoskeletal and connective tissue disorders
shooting pains in the left flank
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Injury, poisoning and procedural complications
Slight burning sensation in right arm
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Respiratory, thoracic and mediastinal disorders
Itchy nose, itchy and red eyes
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Injury, poisoning and procedural complications
Soreness and a hematoma on the place of a failed arterial catheterization
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Blood and lymphatic system disorders
Normocytemic anemia
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion and irritated eyes
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Injury, poisoning and procedural complications
Feeling of some pressure in outlet of catheters
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat, runny nose and swollen glands
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Musculoskeletal and connective tissue disorders
Swollen and painfull left knee
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose and itchy eyes
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
33.3%
2/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Blood and lymphatic system disorders
Increased frequency of bruising
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Nervous system disorders
Light headed feeling with getting up
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Musculoskeletal and connective tissue disorders
Knee pain (left)
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Blood and lymphatic system disorders
Nose bleeds
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath, which subject attributes to (known) asthma
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
General disorders
Tiredness, headache
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Musculoskeletal and connective tissue disorders
Accident
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Gastrointestinal disorders
Diarrhea and vomiting
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Infections and infestations
Infection finger
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
|
Nervous system disorders
Vertigo
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
0.00%
0/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
16.7%
1/6 • From start of IMP administration up until the last follow up visit 28 days after IMP administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER