Trial Outcomes & Findings for Evaluate the Safety, Tolerability and PK of HF1K16 in Healthy Volunteers (NCT NCT05386823)
NCT ID: NCT05386823
Last Updated: 2024-05-23
Results Overview
Safety evaluation within 8 days after first dose, including frequency of adverse event (AE) and severe adverse event (SAE)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
from Day 1 to Day 8
Results posted on
2024-05-23
Participant Flow
Sixteen subjects were enrolled and randomized to receive active study drug or placebo. All subjects were recruited in medical clinic,Frontage Clinical Services, Inc. started on 20March2021 till 28July2021.
Participant milestones
| Measure |
3 mg/m² HF1K16
6 subjects received 3 mg/m² of study drug
|
6 mg/m² HF1K16
6 subjects received 6 mg/m² of study drug
|
Placebo
4 subjects received placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
4
|
|
Overall Study
COMPLETED
|
6
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate the Safety, Tolerability and PK of HF1K16 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
3 mg/m² HF1K16
n=6 Participants
6 subjects received 3 mg/m² of HF1K16
|
Placebo
n=4 Participants
4 subjects received placebo.
|
6 mg/m² HF1K16
n=6 Participants
6 subjects received 6 mg/m² of HF1K16
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
age
|
37.3 years
n=5 Participants
|
47.3 years
n=7 Participants
|
40 years
n=5 Participants
|
40.8 years
n=4 Participants
|
PRIMARY outcome
Timeframe: from Day 1 to Day 8Population: The analysis population included all participants who exposure to study drug
Safety evaluation within 8 days after first dose, including frequency of adverse event (AE) and severe adverse event (SAE)
Outcome measures
| Measure |
Placebo
n=4 Participants
The subjects received single IV doses of placebo on Day 1
|
HF1K16-3mg/m²
n=6 Participants
Cohort 1: The subjects received 3 mg/m² single IV doses of HF1K16 on Day 1
|
HF1K16-6mg/m²
n=6 Participants
Cohort 2: The subjects received 6 mg/m² single IV doses of HF1K16 on Day 1
|
|---|---|---|---|
|
Number of Participants With Adverse Event (AE) and Severe Adverse Event (SAE)
Subjects with SAE
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Event (AE) and Severe Adverse Event (SAE)
Number of AEs
|
0 participants
|
0 participants
|
4 participants
|
PRIMARY outcome
Timeframe: from Day 1 to Day 8Population: Analysis population includes all participants who received at least one dose of HF1K16 and completed safety follow-up through the DLT evaluation period
DLT is defined as Specify that any one grade ≥ 3 AE will halt dose escalation unless the AE is clearly and incontrovertibly due to extraneous causes; Specify that any two grade ≥ 2 AEs will halt dose escalation unless the AEs are clearly and incontrovertibly due to extraneous causes；Grade 3 asymptomatic laboratory abnormalities that resolved to ≤ grade 1 within 3 days may be excluded from the definition of DLT
Outcome measures
| Measure |
Placebo
n=6 Participants
The subjects received single IV doses of placebo on Day 1
|
HF1K16-3mg/m²
n=6 Participants
Cohort 1: The subjects received 3 mg/m² single IV doses of HF1K16 on Day 1
|
HF1K16-6mg/m²
Cohort 2: The subjects received 6 mg/m² single IV doses of HF1K16 on Day 1
|
|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: pre-infusion (within 60 minutes prior to the start of infusion) and 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, and 48 hours relative to start of infusionPopulation: The PK analysis population included all participants who were compliant with the study procedures and provided sufficient plasma concentrations of tretinoin and 4-oxotretinoin
To evaluate pharmacokinetic parameters of free tretinoin and liposome encapsulated tretinoin (4-oxotretinoin) in plasma after single administration of HF1K16
Outcome measures
| Measure |
Placebo
n=6 Participants
The subjects received single IV doses of placebo on Day 1
|
HF1K16-3mg/m²
n=6 Participants
Cohort 1: The subjects received 3 mg/m² single IV doses of HF1K16 on Day 1
|
HF1K16-6mg/m²
Cohort 2: The subjects received 6 mg/m² single IV doses of HF1K16 on Day 1
|
|---|---|---|---|
|
Peak Drug Concentration (Cmax) After Single Dose of HF1K16
Cmax of tretinoin
|
198 ng/mL
Standard Deviation 45.6
|
409 ng/mL
Standard Deviation 52.3
|
—
|
|
Peak Drug Concentration (Cmax) After Single Dose of HF1K16
Cmax of 4-oxotretinoin
|
3.14 ng/mL
Standard Deviation 0.902
|
7.65 ng/mL
Standard Deviation 0.732
|
—
|
SECONDARY outcome
Timeframe: pre-infusion (within 60 minutes prior to the start of infusion) and 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, and 48 hours relative to start of infusionPopulation: The PK analysis population included all participants who were compliant with the study procedures and provided sufficient plasma concentrations of tretinoin and 4-oxotretinoin
To evaluate pharmacokinetic parameters of free tretinoin and liposome encapsulated tretinoin (4-oxotretinoin) in plasma after single administration of HF1K16
Outcome measures
| Measure |
Placebo
n=6 Participants
The subjects received single IV doses of placebo on Day 1
|
HF1K16-3mg/m²
n=6 Participants
Cohort 1: The subjects received 3 mg/m² single IV doses of HF1K16 on Day 1
|
HF1K16-6mg/m²
Cohort 2: The subjects received 6 mg/m² single IV doses of HF1K16 on Day 1
|
|---|---|---|---|
|
A Summary of Pharmacokinetic Parameters (AUC0-t) After Single Dose of HF1K16
AUC(0-last ) of tretinoin
|
469 h*ng/mL
Standard Deviation 93.3
|
810 h*ng/mL
Standard Deviation 113
|
—
|
|
A Summary of Pharmacokinetic Parameters (AUC0-t) After Single Dose of HF1K16
AUC(0-last ) of 4-oxotretinoin
|
2.58 h*ng/mL
Standard Deviation 1.78
|
9.24 h*ng/mL
Standard Deviation 3.21
|
—
|
SECONDARY outcome
Timeframe: pre-infusion (within 60 minutes prior to the start of infusion) and 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, and 48 hours relative to start of infusionPopulation: The PK analysis population included all participants who were compliant with the study procedures and provided sufficient plasma concentrations of tretinoin and 4-oxotretinoin
o evaluate pharmacokinetic parameters of free tretinoin and liposome encapsulated tretinoin (4-oxotretinoin) in plasma after single administration of HF1K16
Outcome measures
| Measure |
Placebo
n=6 Participants
The subjects received single IV doses of placebo on Day 1
|
HF1K16-3mg/m²
n=6 Participants
Cohort 1: The subjects received 3 mg/m² single IV doses of HF1K16 on Day 1
|
HF1K16-6mg/m²
Cohort 2: The subjects received 6 mg/m² single IV doses of HF1K16 on Day 1
|
|---|---|---|---|
|
A Summary of Pharmacokinetic Parameters (Tmax) After Single Dose of HF1K16
Tmax of tretinoin
|
0.92 h
Interval 0.92 to 0.92
|
0.92 h
Interval 0.92 to 0.93
|
—
|
|
A Summary of Pharmacokinetic Parameters (Tmax) After Single Dose of HF1K16
Tmax of 4-oxotretinoin
|
1.5 h
Interval 1.5 to 2.0
|
1.8 h
Interval 1.5 to 2.0
|
—
|
Adverse Events
3 mg/m² HF1K16
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6 mg/m² HF1K16
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3 mg/m² HF1K16
n=6 participants at risk
Cohort 1: enrolled 6 subjects for 3 mg/m2 of HF1K16
|
6 mg/m² HF1K16
n=6 participants at risk
Cohort 2: enrolled 6 subjects for 6mg/m2 of HF1K16
|
Placebo
n=4 participants at risk
Cohort 1: enrolled 2 subjects for placebo Cohort 2: enrolled 2 subjects for placebo
|
|---|---|---|---|
|
General disorders
Feeling hot
|
0.00%
0/6 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
16.7%
1/6 • Number of events 1 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
0.00%
0/4 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
|
General disorders
Chest pain
|
0.00%
0/6 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
16.7%
1/6 • Number of events 1 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
0.00%
0/4 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
16.7%
1/6 • Number of events 1 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
0.00%
0/4 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
16.7%
1/6 • Number of events 1 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
0.00%
0/4 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
16.7%
1/6 • Number of events 1 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
0.00%
0/4 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
16.7%
1/6 • Number of events 1 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
0.00%
0/4 • All AEs (serious and non-serious) were collected from signing the ICF and throughout the study to the follow-up/completion visit. A follow-up telephone call was placed to all subjects on Day 8 (± 2 days) to collect adverse event (AE) and concomitant medication information.
|
Additional Information
Dr. Yuhong Xu
HighField BioPharmaceuticals Corporation
Phone: +86-571-86961869
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place