NCT06938763

Evaluation of the Safety, Tolerability, and Pharmacokinetics of J4 in Healthy Adults

A Phase I, Randomized, Double-blinded, Placebo-Controlled First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of J4 Dry Powder Capsule After Oral Administration of Single and Multiple Ascending Doses to Healthy Adults

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Academia Sinica, Taiwan · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

A Phase I, Randomized, Double-blinded, Placebo-Controlled First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of J4 Dry Powder Capsule after Oral Administration of Single and Multiple Ascending Doses to Healthy Adults

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	J4	dry powder capsule
DRUG	Placebo	Placebo dry powder capsule

Timeline

• Start date: 2025-02-14
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-04-22
• Last updated: 2026-01-06

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study