Trial Outcomes & Findings for Study of AT-752 in Patients With Dengue Infection (NCT NCT05466240)
NCT ID: NCT05466240
Last Updated: 2024-03-05
Results Overview
To investigate the antiviral activity of AT-752 versus placebo in terms of reduction of DENV RNA from baseline in adult subjects with confirmed DENV infection
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 28
Results posted on
2024-03-05
Participant Flow
Participant milestones
| Measure |
AT-752 750-mg TID for 5 Days
Tablet; 750-mg, Three (3) times a day for 5-days
AT-752: AT-752 for 5 days
|
Placebo TID for 5 Days
Tablet; Placebo, Three (3) times a day for 5-days
Placebo: Placebo for 5 days
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
7
|
|
Overall Study
COMPLETED
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
AT-752 750-mg TID for 5 Days
Tablet; 750-mg, Three (3) times a day for 5-days
AT-752: AT-752 for 5 days
|
Placebo TID for 5 Days
Tablet; Placebo, Three (3) times a day for 5-days
Placebo: Placebo for 5 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study of AT-752 in Patients With Dengue Infection
Baseline characteristics by cohort
| Measure |
AT-752 750-mg TID for 5 Days
n=14 Participants
Tablet; 750-mg, Three (3) times a day for 5-days
AT-752: AT-752 for 5 days
|
Placebo TID for 5 Days
n=7 Participants
Tablet; Placebo, Three (3) times a day for 5-days
Placebo: Placebo for 5 days
|
Total
n=21 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
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 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
|
31.1 years
STANDARD_DEVIATION 8.53 • n=5 Participants
|
28.0 years
STANDARD_DEVIATION 5.54 • n=7 Participants
|
30.1 years
STANDARD_DEVIATION 7.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
India
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 28Population: Number of subjects with available viral load for baseline and the particular post-baseline timepoint.
To investigate the antiviral activity of AT-752 versus placebo in terms of reduction of DENV RNA from baseline in adult subjects with confirmed DENV infection
Outcome measures
| Measure |
AT-752 750-mg TID for 5 Days
n=13 Participants
Tablet; 750-mg, Three (3) times a day for 5-days
AT-752: AT-752 for 5 days
Placebo: Placebo for 5 days
|
Placebo TID for 5 Days
n=7 Participants
Tablet; Placebo, Three (3) times a day for 5-days
Placebo: Placebo for 5 days
|
|---|---|---|
|
Change in Dengue (DENV) Viral Load From Baseline
Baseline Viral Load
|
5.8 log10 copies/mL
Standard Deviation 2.0
|
4.6 log10 copies/mL
Standard Deviation 2.5
|
|
Change in Dengue (DENV) Viral Load From Baseline
Day 2
|
-1.3 log10 copies/mL
Standard Deviation 1.1
|
-0.8 log10 copies/mL
Standard Deviation 0.9
|
|
Change in Dengue (DENV) Viral Load From Baseline
Day 3
|
-2.8 log10 copies/mL
Standard Deviation 1.3
|
-1.2 log10 copies/mL
Standard Deviation 1.3
|
|
Change in Dengue (DENV) Viral Load From Baseline
Day 4
|
-3.3 log10 copies/mL
Standard Deviation 1.8
|
-1.2 log10 copies/mL
Standard Deviation 1.7
|
|
Change in Dengue (DENV) Viral Load From Baseline
Day 5
|
-3.3 log10 copies/mL
Standard Deviation 1.8
|
-1.8 log10 copies/mL
Standard Deviation 2.6
|
|
Change in Dengue (DENV) Viral Load From Baseline
Day 6
|
-3.3 log10 copies/mL
Standard Deviation 1.8
|
-1.9 log10 copies/mL
Standard Deviation 2.5
|
|
Change in Dengue (DENV) Viral Load From Baseline
Day 8
|
-3.4 log10 copies/mL
Standard Deviation 1.8
|
-1.9 log10 copies/mL
Standard Deviation 2.5
|
|
Change in Dengue (DENV) Viral Load From Baseline
Day 14
|
-3.3 log10 copies/mL
Standard Deviation 1.9
|
-1.9 log10 copies/mL
Standard Deviation 2.5
|
|
Change in Dengue (DENV) Viral Load From Baseline
Day 28
|
-3.4 log10 copies/mL
Standard Deviation 1.8
|
-1.9 log10 copies/mL
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dosePopulation: PK Population
Maximum plasma concentration (Cmax) of AT-281
Outcome measures
| Measure |
AT-752 750-mg TID for 5 Days
n=11 Participants
Tablet; 750-mg, Three (3) times a day for 5-days
AT-752: AT-752 for 5 days
Placebo: Placebo for 5 days
|
Placebo TID for 5 Days
Tablet; Placebo, Three (3) times a day for 5-days
Placebo: Placebo for 5 days
|
|---|---|---|
|
Pharmacokinetic (PK) Endpoint
|
2390 ng/mL
Standard Deviation 2460
|
—
|
SECONDARY outcome
Timeframe: Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dosePopulation: PK Population
Area under the concentration-time curve (AUCtau) of AT-281
Outcome measures
| Measure |
AT-752 750-mg TID for 5 Days
n=11 Participants
Tablet; 750-mg, Three (3) times a day for 5-days
AT-752: AT-752 for 5 days
Placebo: Placebo for 5 days
|
Placebo TID for 5 Days
Tablet; Placebo, Three (3) times a day for 5-days
Placebo: Placebo for 5 days
|
|---|---|---|
|
Pharmacokinetic (PK) Endpoint
|
4270 h*ng/mL
Standard Deviation 2750
|
—
|
Adverse Events
AT-752 750-mg TID for 5 Days
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo TID for 5 Days
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AT-752 750-mg TID for 5 Days
n=14 participants at risk
Tablet; 750-mg, Three (3) times a day for 5-days
AT-752: AT-752 for 5 days
|
Placebo TID for 5 Days
n=7 participants at risk
Tablet; Placebo, Three (3) times a day for 5-days
Placebo: Placebo for 5 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
1/14 • Number of events 1 • Day 28
|
14.3%
1/7 • Number of events 1 • Day 28
|
Other adverse events
| Measure |
AT-752 750-mg TID for 5 Days
n=14 participants at risk
Tablet; 750-mg, Three (3) times a day for 5-days
AT-752: AT-752 for 5 days
|
Placebo TID for 5 Days
n=7 participants at risk
Tablet; Placebo, Three (3) times a day for 5-days
Placebo: Placebo for 5 days
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
21.4%
3/14 • Day 28
|
42.9%
3/7 • Day 28
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
2/14 • Day 28
|
28.6%
2/7 • Day 28
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Day 28
|
14.3%
1/7 • Day 28
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Day 28
|
57.1%
4/7 • Day 28
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
2/14 • Day 28
|
28.6%
2/7 • Day 28
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
2/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
2/14 • Day 28
|
14.3%
1/7 • Day 28
|
|
General disorders
Fatigue
|
0.00%
0/14 • Day 28
|
28.6%
2/7 • Day 28
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
14.3%
2/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/14 • Day 28
|
14.3%
1/7 • Day 28
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Day 28
|
14.3%
1/7 • Day 28
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/14 • Day 28
|
14.3%
1/7 • Day 28
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Metabolism and nutrition disorders
Euglycaemic diabetic ketoacidosis
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Investigations
Blood creatine phosphokinase increased
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Investigations
Hematocrit increased
|
0.00%
0/14 • Day 28
|
14.3%
1/7 • Day 28
|
|
Hepatobiliary disorders
Cholecystitis
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/14 • Day 28
|
14.3%
1/7 • Day 28
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Eye disorders
Eye pain
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/14 • Day 28
|
14.3%
1/7 • Day 28
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
|
Vascular disorders
Phlebitis
|
7.1%
1/14 • Day 28
|
0.00%
0/7 • Day 28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator may publish or present results pertaining to the PI's activities after the first publication of the multicentre clinical trial results. Publications must be submitted for review by Sponsor before submission. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER