Evaluating Single and Multiple Doses of an Optimized Subcutaneous Formulation of BHV-1300 in a Phase 1, Randomized, Open-Label, Placebo-Controlled Study

Evaluating Single and Multiple Doses of an Optimized Subcutaneous Formulation of BHV-1300 in Healthy Adults in a Phase 1, Randomized, Open-Label, Placebo-Controlled Study

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624001129572

Enrollment

Registered

2024-09-18

Start date

2024-10-28

Completion date

2025-03-24

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

BHV-1300 is being developed by Biohaven Therapeutics Limited for the potential treatment of immune-mediated diseases. This is a single center, Phase 1, randomized, open-label, placebo controlled, single and multiple dose study in healthy adults. This study will include single and multiple dose cohorts to evaluate the safety and tolerability of BHV-1300 and to characterize the pharmacokinetic profile of BHV-1300.

Interventions

The study has 2 parts: Part 1: Participants will receive a single dose of BHV-1300 or placebo as a subcutaneous injection. Part 2: Participants will receive BHV-1300 or placebo dosed weekly for 4 weeks as a subcutaneous injection. The planned dose range across Part 1 & 2 is up to 2000mg of BHV-1300 or placebo. The doses will be administered while as an inpatient at the clinic by delegated study site personnel and documented in study notes.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Male or non-childbearing potential female, non-users of tobacco or nicotine products within 3 months prior to Screening, 18 to 55 years of age (inclusive), with BMI 18.0 to 30.0 kg/m2 (inclusive). 2. Healthy as defined by: a. The absence of clinically significant illness and surgery within 12 weeks prior to dosing. b. The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, hepatobiliary, renal, and metabolic disease.

Exclusion criteria

1. History of a clinically significant bacterial, fungal, parasitic, viral, or mycobacterial infection within 90 days prior to screening. 2. History of recurrent respiratory tract infections (including bronchitis, viral or bacterial pneumonia, sinusitis).

Outcome results