A Randomized, Double-blind, Single-dose, Placebo-controlled Pharmacokinetic and Proof-of-concept Study to Evaluate the Safety of CYT-1010 in Healthy Volunteers and in Subjects With Moderate to Severe Pain After Third Molar Extraction

Cytogel Pharma, LLC

Summary

The primary objective of this trial is to assess the safety and tolerability of single, ascending doses of CYT-1010 in healthy male and female volunteers and in the treatment of acute postoperative pain after third molar extraction.

Eligibility

Age range: 18–45 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: 1. Be a male or female, 18-45 years of age, able and willing to provide written informed consent to participate in the trial. 2. Be in generally good health as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG). 3. Have body mass index (BMI) of 19-35 kg/m\^2. 4. (Healthy Volunteer participants only): Willing to remain in confinement at the clinical trial unit for 1.5 consecutive days (one night) and to return to the unit at 7±2 days for a final AE assessment and additional blood tests and safety eva…

Interventions

Drug
CYT-1010
Single intravenous (IV) dose of 5 mg or 10 mg CYT-1010.
Drug
Placebo
20% hydroxypropyl-β-cyclodextrin, approximately 0.01 N HCl, IV sterile injection delivered as a single IV dose.

Location

CenExel SLC
Salt Lake City, Utah

A Randomized, Double-blind, Single-dose, Placebo-controlled Pharmacokinetic and Proof-of-concept Study to Evaluate the Safety of CYT-1010 in Healthy Volunteers and in Subjects With Moderate to Severe Pain After Third Molar Extraction

Summary

Eligibility

Interventions

Location

Compensation

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Details

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