Safety, tolerability, pharmacokinetics, and pharmacodynamics of ABP-671 in healthy participants and patients with hyperuricemia and gout: a proof-of-concept study
Authors' conclusion
ABP-671 had an acceptable safety profile in Chinese healthy participants and patients with hyperuricemia and gout. ABP-671 reduced serum urate levels in a dose-dependent manner.
Study context
- Population
- Chinese healthy participants (SAD: 0.5, 1, 3, 6 mg) and patients with hyperuricemia and gout (multiple ascending dose (MAD))SAD 32
- Comparison
- ABP-671 at ascending doses vs placebo
- Primary endpoint
- Safety, tolerability, pharmacokinetics and pharmacodynamics of ABP-671
Methodological detailssingle-centre, double-blind, placebo-controlled, phase I/IIa, single ascending dose (SAD) and multiple ascending dose (MAD) parts, proof-of-concept
- Single-centre
- Double-blind
- Placebo-controlled
- Phase I/IIa
- Single ascending dose (SAD) and multiple ascending dose (MAD) parts
- Proof-of-concept
Primary result
As reported in the abstract
Maximum mean serum urate decrease from baseline, patients with gout (MAD)
Placebo
17.7%
mean
1 mg QD
56.4%
mean
2 mg QD
58.1%
mean
4 mg QD
69.4%
mean
6 mg QD
77.0%
mean
12 mg QD
79.2%
mean
Further findings
| Outcome | Values |
|---|---|
| Maximum mean serum urate decrease from baseline, patients with hyperuricemia (MAD) | Placebo mean 19.9% · 1 mg QD mean 50.1% · 2 mg QD mean 64.1% · 4 mg QD mean 73.2% · 6 mg QD mean 81.2% · 12 mg QD mean 82.1% |
Safety
Participants with TEAEs
Serious AEs (SAEs) and grade ≥ 3 treatment-emergent adverse events (TEAEs)
- No SAEs and no grade ≥ 3 TEAEs
Original publication
Safety, tolerability, pharmacokinetics, and pharmacodynamics of ABP-671 in healthy participants and patients with hyperuricemia and gout: a proof-of-concept study. Arthritis Res Ther. Published 22 June 2026. doi:10.
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