Safety, tolerability, pharmacokinetic, pharmacodynamic and immunogenicity profiles of Exendin‐4‐IgG4‐Fc in healthy subjects: A phase 1, single‐centre, randomized, double‐blind, dose escalation study
Authors' conclusion
E4F4 exhibited an acceptable safety profile and linear pharmacokinetics in healthy subjects. The recommended phase 2 dose is 4.5-10.35 mg once every 2 weeks.
Study context
- Population
- Healthy Chinese subjects
- Participants
- 96 subjects10 sequential cohorts
- Comparison
- Single SC injection of E4F4 vs placebo
- Primary endpoint
- Safety and tolerability of E4F4
Methodological detailsphase 1, single-centre, double-blind, placebo-controlled, dose escalation, first-in-human, Safety data to day 15 after the final subject in a cohort were reviewed before the next dose level
- Phase 1
- Single-centre
- Double-blind
- Placebo-controlled
- Dose escalation
- First-in-human
- Safety data to day 15 after the final subject in a cohort were reviewed before the next dose level
Primary result
As reported in the abstract
Safety and tolerability
- E4F4 was safe and well tolerated
- No obvious dose-dependent relationship between frequency, severity or causality of treatment-emergent adverse events
Secondary outcomes
Pharmacokinetics
- Median Tmax range across doses
- 146 to 210 h
- Median t1/2 range across doses
- 199 to 252 h
- Cmax and AUC dose proportional over 0.45-14.85 mg
- No dose-dependent trends in Tmax and t1/2
IV glucose tolerance test: plasma glucose AUC 0–180 min
- Dose-response relationship in the 1.8-10.35 mg range, with increased response at higher doses
Safety
Treatment-emergent adverse events
- No obvious dose-dependent relationship between frequency, severity or causality of TEAEs
Original publication
Safety, tolerability, pharmacokinetic, pharmacodynamic and immunogenicity profiles of Exendin‐4‐IgG4‐Fc in healthy subjects: A phase 1, single‐centre, randomized, double‐blind, dose escalation study. Diabetes Obes Metab. Published 29 January 2024. doi:10.
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