CompletedPhase 1

Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3

Australia31 participantsStarted 2023-03-08

Plain-language summary

This will be a single centre, Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Male or female, non-smoker, 18 to 60 years of age (both inclusive),
✓. Healthy as defined by:
✓. the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration in the opinion of the investigator.
✓. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease in the opinion of the investigator.

Exclusion criteria

✕. Abnormal finding at physical examination
✕. Evidence of clinical significant hepatic or renal impairment
✕. Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, or positive test results for COVID-19, or QuantiFERON®-TB test at screening.
✕. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

What they're measuring

To evaluate the safety and tolerability of APB-R3 following IV administration of single ascending dose in healthy participants.

Timeframe: Upto 92 days

Trial details

NCT IDNCT05715736

SponsorSyneos Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-19

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