Trial reportBMC medicine2026
Phase 1 randomized trial of HS-10353, a novel GABA(A) positive allosteric modulator for treatment of major depressive disorder.
Trial report in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05195203 (A Phase I Randomized, Double-blinded, Placebo-controlled Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of HS-10353 in Chinese Adult Subjects), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I Randomized, Double-blinded, Placebo-controlled Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of HS-10353 in Chinese Adult Subjects
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHS-10353 is a novel positive allosteric modulator of γ-aminobutyric acid A receptors that is under development for the treatment of major depressive disorder (MDD).
methodsThis is a double-blind, randomized, placebo-controlled, phase 1 trial comprising single ascending dose (SAD) and multiple ascending dose (MAD) parts. In SAD, 8 healthy volunteers of each cohort were randomized (6:2) to receive HS-10353 (2-55 mg) or placebo in a fasted state. In MAD, 12 MDD patients of each cohort were randomized (9:3) to receive HS-10353 (15-65 mg/day given for up to 7 days) or placebo. The primary objective was to assess the safety and tolerability of HS-10353. The efficacy endpoint in the MAD part included the change in the total score of the 17-item Hamilton Rating Scale for Depression (HAM-D17) at day 8. Pharmacokinetic (PK) analysis was performed as a secondary objective.
resultsForty-eight healthy participants and forty-eight MDD participants completed the study. The most frequently observed treatment emergent adverse events (TEAEs) in the HS-10353 dose groups (occurring in ≥ 3 cases) included white blood cells urine positive and alanine aminotransferase increased in the SAD part, white blood cell count decreased and somnolence in the MAD part. All adverse events (AEs) were mild to moderate, and there were no serious adverse events or AEs that led to withdrawal from the trial. Treatment with 50 mg of HS-10353 for only 7 days showed therapeutic effects, with a difference of -4.7 (95% CI: -8.9 to -0.5) in change from baseline of HAM-D17 score on day 8 compared to placebo. HS-10353 exhibited a terminal half-life of 14 to 22 h with minimal accumulation upon repeat dosing (approximately 1.3- to 2.5-fold), supporting once-daily dosing; while absorption saturation was observed at fasting dose levels greater than 45 mg.
conclusionsSingle and multiple oral doses of HS-10353 were safe and well tolerated with a favorable PK profile. The findings in this small, short duration study suggest an early signal in patients with MDD that should be further investigated.
trial registrationThe trial is registered at China Drug Trials (CTR20210105, 2021-01-21) and ClinicalTrials.gov (NCT05195203, 2022-01-13).
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.