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BF844 Safety and Pharmacokinetic Study in Healthy Volunteers
First-in-Human Phase-1 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of BF844 when Administered Orally to Healthy Adult Participants.
Study details:
This is a first-in-human, single center, randomized, double-blinded, single and multiple ascending doses (SAD and MAD) and food effect Phase I study in healthy adult volunteers (HV). The SAD cohorts will consist of five cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 40 HV). Additional cohorts may be added.
The food effect (FE) cohort will consist of 12 participants who receive a single dose of BF844 in a cross-over manner. Each participants will receive the same single dose of BF844 under two separate conditions: one after an overnight fast, and the second following a high-fat breakfast 30 minutes prior to dosing. The MAD cohorts will consist of 3 cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 24 HV).
The subjects in MAD cohorts will be dosed once daily for 7 consecutive days. Additional cohorts may be added. For each cohort, all HV subjects will be enrolled at the same site To optimise participants safety, BF844 will be administered in a staggered manner as per protocol .
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-09-09
Primary completion: 2025-03-06
Study completion finish: 2025-09-06
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06592131
Intervention or treatment
DRUG: BF844
Conditions
- • Usher Syndrome Type 3
Find a site
Closest Location:
Linear Clinical Research
Research sites nearby
Select from list below to view details:
Linear Clinical Research
Perth, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Cohort-1 First dose of SAD cohort (6 treatment + 2 placebo)
| DRUG: BF844
|
EXPERIMENTAL: Cohort-2 Second dose of SAD cohort (6 treatment + 2 placebo)
| DRUG: BF844
|
EXPERIMENTAL: Cohort-3 Third dose of SAD cohort (6 treatment + 2 placebo)
| DRUG: BF844
|
EXPERIMENTAL: Cohort-4 Fourth dose of SAD cohort (6 treatment + 2 placebo)
| DRUG: BF844
|
EXPERIMENTAL: Cohort-5 Fifth dose of SAD cohort (6 treatment + 2 placebo)
| DRUG: BF844
|
EXPERIMENTAL: Cohort-6 Using one of the BF844 doses(with/without food) that were tested in SAD
| DRUG: BF844
|
EXPERIMENTAL: Cohort-7 First dose of MAD cohort (6 treatment + 2 placebo)
| DRUG: BF844
|
EXPERIMENTAL: Cohort 8 Second dose of MAD cohort (6 treatment + 2 placebo)
| DRUG: BF844
|
EXPERIMENTAL: Cohort 9 Third dose of MAD cohort (6 treatment + 2 placebo)
| DRUG: BF844
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants. | Percentage of participants who experience at least 1 treatment-emergent adverse event (TEAE). | Baseline and 14 Days |
To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants. | Percentage of participants who discontinue due to an adverse event (AE). | Baseline and 14 Days |
To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants. | Percentage of participants who meet the clinically significant criteria for safety laboratory tests at least once post dose. | Baseline and 14 Days |
To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants. | Percentage of participants who meet the clinically significant criteria for vital sign measurements at least once post dose. | Baseline and 14 Days |
To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants. | Percentage of participants who meet the clinically significant criteria for safety electrocardiogram (ECG) parameters at least once post dose. | Baseline and 14 Days |
To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants. | Treatment-emergent hearing, vision, or balance abnormalities, as measured by audiometry, visual acuity, and clinical examination. | Baseline and 14 Days |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
To determine the effect of food on the absorption of BF844 when administered as a single oral dose in healthy participants. | Plasma PK parameters of BF844 at the dose level selected for the food effect study: t1/2 | Baseline and 24 hours |
To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants. | Plasma PK parameters of BF844 at each dose level: Cmax | Baseline and 7 days |
To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants. | Plasma PK parameters of BF844 at each dose level: AUClast | Baseline and 7 days |
To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants. | Plasma PK parameters of BF844 at each dose level: AUC∞ | Baseline and 7 days |
To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants. | Plasma PK parameters of BF844 at each dose level: t1/2 | Baseline and 7 days |
To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants. | Urine PK parameters of BF844 at each dose level: AUC0-24hrs | Baseline and 7 days |
To determine the effect of food on the absorption of BF844 when administered as a single oral dose in healthy participants. | Plasma PK parameters of BF844 at the dose level selected for the food effect study: Cmax | Baseline and 24 hours |
To determine the effect of food on the absorption of BF844 when administered as a single oral dose in healthy participants. | Plasma PK parameters of BF844 at the dose level selected for the food effect study: tmax | Baseline and 24 hours |
To determine the effect of food on the absorption of BF844 when administered as a single oral dose in healthy participants. | Plasma PK parameters of BF844 at the dose level selected for the food effect study: AUClast | Baseline and 24 hours |
To determine the effect of food on the absorption of BF844 when administered as a single oral dose in healthy participants. | Plasma PK parameters of BF844 at the dose level selected for the food effect study: AUC∞ | Baseline and 24 hours |
To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants. | Plasma PK parameters of BF844 at each dose level: tmax | Baseline and 7 days |
To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants. | Plasma PK parameters of BF844 at each dose level: AUCτ | Baseline and 7 days |
To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants. | Urine PK parameters of BF844 at each dose level: Accumulation factor | Baseline and 7 days |
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