A randomized first-in-human study of a novel growth hormone receptor peptide antagonist ALXN2420 in healthy subjects
Authors' conclusion
ALXN2420 doses of up to 120 mg/day appeared to be safe and substantially decreased IGF-1 levels in healthy subjects
Study context
- Population
- Healthy subjectseligible and evaluable
- Participants
- 101 subjects
- Comparison
- ALXN2420 vs placebo
- Primary endpoint
- Safety and tolerability
Methodological detailsphase 1, first-in-human, double-blind, placebo-controlled, single ascending dose (SAD), 2-week multiple ascending dose (MAD), single-centre
- Phase 1
- First-in-human
- Double-blind
- Placebo-controlled
- Single ascending dose (SAD)
- 2-week multiple ascending dose (MAD)
- Single-centre
Primary result
As reported in the abstract
- ALXN2420 SC up to 120 mg/day well tolerated, with no safety concerns
Further findings
Pharmacokinetics
- Terminal half-life
- ≈22 hours
- PK parameters increased dose proportionally
Serum IGF-1
- Maximal mean change from baseline vs placebo in IGF-1, doses ≥40 mg, SAD
- ≈20% to 30%
- Maximal mean change from baseline vs placebo in IGF-1, doses ≥40 mg, MAD
- 40% to 50%
- Dose-related IGF-1 decreases at doses ≥20 mg, more prolonged at higher doses (up to 72 hours SAD; to end of treatment MAD)
- Repeated daily dosing for 2 weeks suggested cumulative effect vs single administration
Safety
- Well tolerated up to 120 mg/day, no safety concerns
Original publication
A randomized first-in-human study of a novel growth hormone receptor peptide antagonist ALXN2420 in healthy subjects. Eur J Endocrinol. Published 10 August 2026. doi:10.
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