Study of AT-752 in Patients With Dengue Infection

• AT-752 (Drug): AT-752 for 5 days
• Placebo (Drug): Placebo for 5 days

Primary outcomes

• Change in Dengue (DENV) Viral Load From Baseline [Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 28]: 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

Secondary outcomes

• Pharmacokinetic (PK) Endpoint [Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose]: Maximum plasma concentration (Cmax) of AT-281
• Pharmacokinetic (PK) Endpoint [Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose]: Area under the concentration-time curve (AUCtau) of AT-281

Sex: All, ages: 18 Years to 55 Years

Key Inclusion Criteria:

* 18-55 years of age at time of screening
* Fever ≥38°C (or feeling feverish) with onset during the previous 48 hours
* Live/work in or recent travel to dengue endemic area
* Positive test confirming Dengue (DENV) on a NS1 antigen test or reverse transcription-polymerase chain reaction (RT-PCR) assay
* Negative rapid diagnostic test result for Coronavirus (SARS-CoV-2) and Influenza A and B

Key Exclusion Criteria:

* Pregnant, plans to become pregnant within 90 days of screening, or breast feeding.
* Has previously received any investigational or approved vaccine for dengue
* Previous history of HIV, chronic hepatitis B infection, or current hepatitis C infection (from medical history)
* Use of any antiviral drug within 30 days or within 5 half-lives of the active drug or metabolite (for long-acting antivirals)
* Current use of anticoagulant or antiplatelet drugs or documented medical history of bleeding disorders
* Current use of medications for treatment of inflammatory bowel disease or documented medical history of chronic gastrointestinal disease including inflammatory bowel disease
* Immunocompromised due to use of immunosuppressive drugs including systemic corticosteroids (inhaled or topical corticosteroids are allowed) or any current disease or condition
* Evidence of severe dengue disease
* Confirmed or suspected Coronavirus (SARS-CoV-2) infection or contact with patients with confirmed SARS-CoV2 infection within 7 days prior to screening
* Other clinically significant medical conditions or laboratory abnormalities, as described in the protocol.

Participant flow

Outcome results

• Change in Dengue (DENV) Viral Load From Baseline (Primary), Mean, log10 copies/mL: AT-752 750-mg TID for 5 Days 5.8 +/- 2.0; Placebo TID for 5 Days 4.6 +/- 2.5 (p <0.95)
• Pharmacokinetic (PK) Endpoint (Secondary), Mean, ng/mL: AT-752 750-mg TID for 5 Days 2390 +/- 2460
• Pharmacokinetic (PK) Endpoint (Secondary), Mean, h*ng/mL: AT-752 750-mg TID for 5 Days 4270 +/- 2750

Adverse events

Time frame: Day 28

Serious adverse events by term

Other adverse events by term

Limitations and caveats: Early discontinuation leading to small numbers of subjects analyzed.

• Study Protocol: Original Protocol (PDF, 2021-09-20)
• Study Protocol: Amendment 1 (PDF, 2022-07-29)
• Statistical Analysis Plan (PDF, 2022-11-15)