Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse EventsPrimary· Up to Day 15
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. A TEAE (treatment-emergent adverse event) was defined as an AE that emerges, having been absent prior to the study, or an AE that worsens in severity after the first dose of the study drug. Serious AE (SAE) was an AE resulting in any of the following outcomes: death; life-threatening adverse event, required hospitalization or prolongation of existing hospitalization; persist
Any TEAE
Group
Value
95% CI
Cohort 1: 4 mg/kg
2
Cohort 2: 8 mg/kg
3
Any SAE
Group
Value
95% CI
Cohort 1: 4 mg/kg
0
Cohort 2: 8 mg/kg
0
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of OP-101Secondary· Pre-dose, 0.5 hours and 1, 2, 4, 6, 8, 10, 12, 16, 24, 30-36, 48 hours post-dose
Cmax: maximum observed plasma concentration.
Group
Value
95% CI
Cohort 1: 4 mg/kg
3.473
± 0.8183
Cohort 2: 8 mg/kg
6.640
± 0.6073
Pharmacokinetics: Time to Reach Maximum Plasma Concentration (Tmax) of OP-101Secondary· Pre-dose, 0.5 hours and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 30-36, 48 hours post-dose
Tmax: time to reach maximum observed plasma concentration.
Group
Value
95% CI
Cohort 1: 4 mg/kg
14.015
10.00 – 16.05
Cohort 2: 8 mg/kg
16.000
12.00 – 24.05
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of OP-101Secondary· Pre-dose, 0.5 hours and 1, 2, 4, 6, 8, 10, 12, 16, 24, 30-36, 48 hours post-dose
AUC0-last: Area under the concentration versus time curve from time zero to the last quantifiable concentration (Clast).
Group
Value
95% CI
Cohort 1: 4 mg/kg
80.940
± 51.8190
Cohort 2: 8 mg/kg
212.325
± 30.6459
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to 48 Hour Post Dose Time Point (AUC0-48) of OP-101Secondary· Pre-dose, 0.5 hours and 1, 2, 4, 6, 8, 10, 12, 16, 24, 30-36, 48 hours post-dose
Area under the concentration versus time curve from time zero to 48 hour post dose time point.
Group
Value
95% CI
Cohort 1: 4 mg/kg
121.705
± 16.9069
Cohort 2: 8 mg/kg
222.173
± 12.4690
Pharmacokinetics: Renal Clearance (CLR) for OP-101Secondary· Pre-dose, 0 to 4, 4 to 8, 8 to 12, 12 to 18, 18 to 24, and 24 to 48 hours post dose
CLR was defined as renal clearance of the drug from plasma utilizing the AUC and cumulative amount of unchanged study drug excreted into the urine (Ae) to the same duration (as Amount recovered/AUC at 0-48 hours).
Group
Value
95% CI
Cohort 1: 4 mg/kg
0.175
± 0.0354
Cohort 2: 8 mg/kg
0.150
± 0.0606
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Day 15.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Orpheris, Inc.
Last refreshed: 14 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04321980.