Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered (NCT NCT05332340)

NCT ID: NCT05332340

Last Updated: 2025-03-07

Results Overview

Peak Plasma Concentration

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
• Results posted on: 2025-03-07

Participant Flow

Participant milestones

Measure	Healthy Patients Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered

Baseline characteristics by cohort

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Age, Continuous Healhty Participants	39.30 years STANDARD_DEVIATION 9.18 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose

Peak Plasma Concentration

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Cmax	NA ng/mL Standard Deviation NA Below the level of detection

PRIMARY outcome

Timeframe: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose

Terminal half-life of BZ371A

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
T1/2	NA minutes Standard Deviation NA Below the level of detection

PRIMARY outcome

Timeframe: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose

Area under the curve (AUC) of plasma/serum/blood drug concentration-time curve

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
AUC	NA ng*min Standard Deviation NA Below the level of detection

PRIMARY outcome

Timeframe: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose

Clearance of BZ371A

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Clearance (CL)	NA mL/min Standard Deviation NA Below the level of detection

PRIMARY outcome

Timeframe: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose

Distribution Volume of BZ371A

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Vd	NA mL Standard Error NA Below the level of detection

PRIMARY outcome

Timeframe: All adverse effect will be collected from the beginning of the study up to one week after drug administration

Number of Adverse Effects after compound application

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Adverse Effects Evaluation	2 adverse events

PRIMARY outcome

Timeframe: Baseline and 1 week

Number of participants with abnormal physical exam findings

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Physical Exam	0 participants

PRIMARY outcome

Timeframe: Baseline and 1 week

Number of participants with a significant change in Systolic Blood Pressure

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Change in SBP	1 participants

PRIMARY outcome

Timeframe: Baseline and 1 week

Number of participants with a significant change in Diastolic Blood Pressure

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Change in DBP	2 participants

PRIMARY outcome

Timeframe: Baseline and 1 week

Change in Heart Rate (HR).

The data from this measure reflect changes calculated from the baseline.

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Change in Heart Rate	69.42 bpm Standard Deviation 12

PRIMARY outcome

Timeframe: Baseline and 1 week

Change in Respiratory Rate (RR).

The data from this measure reflect changes calculated from the baseline.

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Change in Respiratory Rate	19 breaths per minute Standard Deviation 1

PRIMARY outcome

Timeframe: Baseline and 1 week

Temperature measurements.

The data from this measure reflect changes calculated from the baseline.

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Change in Temperature	0.1 degrees Celsius Standard Deviation 0.36

PRIMARY outcome

Timeframe: Baseline and 1 week

Number of participants with abnormal ECG readings

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Basal Chest Electrocardiogram (ECG)	0 participants

PRIMARY outcome

Timeframe: Baseline and 1 day

Number of participants with abnormal laboratory test results

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Blood Evaluation	0 participants

PRIMARY outcome

Timeframe: Baseline and 1 week

Number of participants with abnormal urinalysis

Outcome measures

Measure	Healthy Patients n=12 Participants Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Urine Evaluation	0 participants

Adverse Events

Healthy Patients

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Healthy Patients n=12 participants at risk Healthy patients receiving topical application of BZ371A BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Vascular disorders Hypotension	16.7% 2/12 • Number of events 2 • 0 to 7 days from compound application 2 participants demonstrated mild Hypotension and 1 participant demonstrated Herpes labialis
General disorders Herpes Labialis	8.3% 1/12 • Number of events 1 • 0 to 7 days from compound application 2 participants demonstrated mild Hypotension and 1 participant demonstrated Herpes labialis

Additional Information

Joaquim Herzog de Oliveira Knox

Biozeus Biopharmaceutical S.A.

Phone: +55 (21) 25239089

Email: joaquim.knox@biozeus.com.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place