Trial Outcomes & Findings for Safety and Efficacy of HB-1 for Panic Disorder (NCT NCT05071430)
NCT ID: NCT05071430
Last Updated: 2025-03-18
Results Overview
Safety was evaluated through Adverse Event monitoring, review of clinically significant changes in routine laboratory tests, ECGs, and orthostatic vital signs. The safety results were presented as: number of subjects reporting an adverse event as percentage of study population that met the eligibility criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
Up to 12 weeks
Results posted on
2025-03-18
Participant Flow
Three participants withdrew prior to receiving study treatment changing 86 to 83 subjects treated.
Participant milestones
| Measure |
Active Treatment (HB-01)
42 patients received HB-01 active study drug.
HB-01: HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
|
Placebo Treatment
41 patients received matched placebo.
Placebo: HB-1 matched placebo
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
| Measure |
Active Treatment (HB-01)
42 patients received HB-01 active study drug.
HB-01: HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
|
Placebo Treatment
41 patients received matched placebo.
Placebo: HB-1 matched placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of HB-1 for Panic Disorder
Baseline characteristics by cohort
| Measure |
Active Treatment (HB-01)
n=42 Participants
44 patients received HB-01 active study drug.
HB-01: HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
|
Placebo Treatment
n=41 Participants
Approximately 42 patients received matched placebo.
Placebo: HB-1 matched placebo
|
Total
n=83 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
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 10.25 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 13.54 • n=7 Participants
|
37.3 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Population - subjects who were randomized and received at least one dose of study drug.
Safety was evaluated through Adverse Event monitoring, review of clinically significant changes in routine laboratory tests, ECGs, and orthostatic vital signs. The safety results were presented as: number of subjects reporting an adverse event as percentage of study population that met the eligibility criteria.
Outcome measures
| Measure |
Active Treatment (HB-01)
n=42 Participants
42 patients received HB-01 active study drug.
HB-01: HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
|
Placebo Treatment
n=41 Participants
41 patients received matched placebo.
Placebo: HB-1 matched placebo
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
|
23 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Panic Disorder Severity Scale Score (PDSS) Change from Baseline (ITT Population)
Percentage of patients who achieved panic free status after 12 weeks"
Outcome measures
| Measure |
Active Treatment (HB-01)
n=44 Participants
42 patients received HB-01 active study drug.
HB-01: HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
|
Placebo Treatment
n=42 Participants
41 patients received matched placebo.
Placebo: HB-1 matched placebo
|
|---|---|---|
|
Change in Panic Disorder Symptom Severity Scale (PDSS)
|
35 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: 3 subjects withdrew before dosing: only 83 treated.
CGI-S is a 7 point scale where 1 indicates "normal, not at all ill" and 7 indicates "amongst the most extremely ill patients".
Outcome measures
| Measure |
Active Treatment (HB-01)
n=42 Participants
42 patients received HB-01 active study drug.
HB-01: HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
|
Placebo Treatment
n=41 Participants
41 patients received matched placebo.
Placebo: HB-1 matched placebo
|
|---|---|---|
|
Change in Clinical Global Impression-Severity Scale (CGI-S)
|
2.95 score on a scale
Standard Deviation 1.053
|
3.33 score on a scale
Standard Deviation 0,986
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Panic Frequency in the Entire ITT Population
The proportion of all subjects achieving panic-free status at the end of the study.
Outcome measures
| Measure |
Active Treatment (HB-01)
n=42 Participants
42 patients received HB-01 active study drug.
HB-01: HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
|
Placebo Treatment
n=42 Participants
41 patients received matched placebo.
Placebo: HB-1 matched placebo
|
|---|---|---|
|
Number of Panic Attacks
|
17 Participants
|
10 Participants
|
Adverse Events
Active Treatment (HB-01)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo Treatment
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Treatment (HB-01)
n=42 participants at risk
42 patients received HB-01 active study drug.
HB-01: HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
|
Placebo Treatment
n=41 participants at risk
41 patients received a matched placebo.
Placebo: HB-1 matched placebo
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/42 • Up to 12 weeks.
|
7.3%
3/41 • Up to 12 weeks.
|
|
Nervous system disorders
dizziness
|
4.8%
2/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Nervous system disorders
lightheadedness
|
2.4%
1/42 • Up to 12 weeks.
|
2.4%
1/41 • Up to 12 weeks.
|
|
Nervous system disorders
migraine
|
2.4%
1/42 • Up to 12 weeks.
|
2.4%
1/41 • Up to 12 weeks.
|
|
Nervous system disorders
dizziness on standing
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Nervous system disorders
Drowsiness
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Nervous system disorders
menstrual migraine
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Nervous system disorders
vestibular migraine
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Infections and infestations
covid-19
|
7.1%
3/42 • Up to 12 weeks.
|
4.9%
2/41 • Up to 12 weeks.
|
|
Infections and infestations
common cold
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Infections and infestations
gastroenteritis
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Infections and infestations
sinus infection
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Infections and infestations
skin infection
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Infections and infestations
stomach virus
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Infections and infestations
URTI
|
0.00%
0/42 • Up to 12 weeks.
|
2.4%
1/41 • Up to 12 weeks.
|
|
Infections and infestations
UTI
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Gastrointestinal disorders
nausea
|
7.1%
3/42 • Up to 12 weeks.
|
4.9%
2/41 • Up to 12 weeks.
|
|
Gastrointestinal disorders
constipation
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Gastrointestinal disorders
diarrhoea
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Gastrointestinal disorders
food poisoning
|
0.00%
0/42 • Up to 12 weeks.
|
2.4%
1/41 • Up to 12 weeks.
|
|
Gastrointestinal disorders
tooth impacted
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/42 • Up to 12 weeks.
|
2.4%
1/41 • Up to 12 weeks.
|
|
Psychiatric disorders
insomnia
|
7.1%
3/42 • Up to 12 weeks.
|
4.9%
2/41 • Up to 12 weeks.
|
|
Psychiatric disorders
bipiolar disorder
|
0.00%
0/42 • Up to 12 weeks.
|
2.4%
1/41 • Up to 12 weeks.
|
|
Psychiatric disorders
nightmares
|
0.00%
0/42 • Up to 12 weeks.
|
2.4%
1/41 • Up to 12 weeks.
|
|
Psychiatric disorders
sleep disturbance
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Psychiatric disorders
vivid dreams
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Vascular disorders
orthostatic hypotension
|
9.5%
4/42 • Up to 12 weeks.
|
9.8%
4/41 • Up to 12 weeks.
|
|
General disorders
fatigue
|
7.1%
3/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
General disorders
flu-like symptoms
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Investigations
increased creatinine clearance
|
0.00%
0/42 • Up to 12 weeks.
|
2.4%
1/41 • Up to 12 weeks.
|
|
Investigations
increased creatinine phosphokinase
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Reproductive system and breast disorders
abnormal uterine bleeding
|
0.00%
0/42 • Up to 12 weeks.
|
2.4%
1/41 • Up to 12 weeks.
|
|
Reproductive system and breast disorders
uterine cramps
|
0.00%
0/42 • Up to 12 weeks.
|
2.4%
1/41 • Up to 12 weeks.
|
|
Immune system disorders
seasonal allergy
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
sensitive skin
|
2.4%
1/42 • Up to 12 weeks.
|
0.00%
0/41 • Up to 12 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place