Phase 1
Completed N=57
Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects
Source: ClinicalTrials.gov NCT04321252 ↗Enrolled (actual)
57
Serious AEs
2.0%
Results posted
Dec 2021
Primary outcomePrimary: Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Deaths — 0; 1; 1; 2 Participants
Summary
This was a randomized, subject and investigator-blinded, placebo-controlled, single and multiple ascending intravenous (iv) dose study in healthy subjects to assess the safety and tolerability of KAE609 given in the vein.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Deaths |
0; 1; 1; 2; 6; 10 | — |
| SECONDARY Part A - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax) |
412; 1510; 2910; 5930; 6590 | — |
| SECONDARY Part A - Pharmacokinetic of KAE609: Time to Reach the Maximum Concentration After Drug Administration (Tmax) |
0.167; 0.0333; 0.333; 0.167; 0.167 | — |
| SECONDARY Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) |
2690; 9540; 25400; 53700; 60800 | — |
| SECONDARY Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) |
2770; 9750; 25600; 57400; 62000 | — |
| SECONDARY Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24hrs) |
1450; 4540; 13500; 23200; 26200 | — |
| SECONDARY Part A - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2) |
27.7; 30.5; 21.9; 38.9; 29.4 | — |
| SECONDARY Part A - Pharmacokinetic of KAE609: Clearance From Plasma (CL) Following Drug Administration |
4330; 3150; 2940; 2430; 3500 | — |
| SECONDARY Part A - Pharmacokinetic of KAE609: Apparent Volume of Distribution During Terminal Phase (Vz) |
154000; 138000; 92900; 124000; 151000 | — |
| SECONDARY Part B - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax) |
3920; 4530; 4630; 5540 | — |
| SECONDARY Part B - Pharmacokinetic of KAE609: Time to Reach the Maximum Concentration After Drug Administration (Tmax) |
0.100; 0.167; 0.0333; 0.167 | — |
| SECONDARY Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) |
58500; 121000 | — |
| SECONDARY Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24hrs) |
13200; 16500; 20000; 40600 | — |
| SECONDARY Part B - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2) |
25.0; 18.1; 35.5; 31.9 | — |
| SECONDARY Part B - Pharmacokinetic of KAE609: Clearance From Plasma (CL) Following Drug Administration |
3140; 3160 | — |
| SECONDARY Part B - Pharmacokinetic of KAE609: Apparent Volume of Distribution During Terminal Phase (Vz) |
175000; 173000 | — |
Eligibility Criteria
Key Inclusion Criteria
- Healthy male and female subjects 18 to 55 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
- Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.0 - 30.0 kg/m2.
Key Exclusion Criteria
- Use of other investigational drugs within 5 half-lives of Screening, or within 30 days of dosing, whichever is longer; or longer if required by local regulations.
- Significant illness which has not resolved within two (2) weeks prior to initial dosing.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
- Sexually active males unwilling to use a condom during intercourse while taking investigational drug and for at least 2 weeks after last dose of investigational drug.
Data sourced from ClinicalTrials.gov (NCT04321252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.