A Phase 1/2 interventional study of CYT-1010 and Placebo in Acute Postoperative Pain and Dental Pain, sponsored by Cytogel Pharma, LLC. Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Cytogel Pharma, LLC · Phase 1/2, Interventional, and Treatment
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 32 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with Cytogel Pharma, LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in Cohort 1a will receive a single 5 mg intravenous dose of CYT-1010.
Drug: CYT-1010
Participants in Cohort 2a will receive a single 10 mg intravenous dose of CYT-1010.
Drug: CYT-1010
Participants in Cohorts 1a and 2a will receive a single intravenous dose of matching placebo.
Drug: Placebo
Participants in Cohort 1b will receive a single 5 mg intravenous dose of CYT-1010.
Drug: CYT-1010
Participants in Cohort 2b will receive a single 10 mg intravenous dose of CYT-1010.
Drug: CYT-1010
Participants in Cohorts 1b and 2b will receive a single intravenous dose of matching placebo.
Drug: Placebo
Single intravenous (IV) dose of 5 mg or 10 mg CYT-1010.
20% hydroxypropyl-β-cyclodextrin, approximately 0.01 N HCl, IV sterile injection delivered as a single IV dose.
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From trial drug administration through Day 7
Sum of Pain Intensity Differences (SPID) Over 2 Hours (SPID2) in Dental Pain Participants
SPID2 is the time-weighted SPID over 0-2 hours after receiving medication, derived from postoperative dental pain assessed on a 0-10 numerical rating scale (NRS). NRS is a categorical 0-10 pain rating scale wherein 0 is defined as "no pain" and 10 is the "pain as bad as you can imagine". Higher scores indicate a greater level of pain intensity.
Time frame: From pre-dose to 2 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Time to Cmax (Tmax) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Area Under the Concentration-time Curve (AUC) From 0 to Last Measurable Concentration (AUC0-t) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
AUC From 0 to Infinity (AUC0-inf) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Elimination Rate Constant (Kel) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Apparent total body clearance (CL) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Total Volume of Distribution (Vss) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Elimination Half-life (T1/2) of CYT-1010 of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Oxygen (O2) Saturation AUC
Time frame: Pre-dose through 8 hours post-dose
Transcutaneous Partial Pressure of Carbon Dioxide (pCO2) AUC
Time frame: Pre-dose through 8 hours post-dose
Respiratory rate AUC
Time frame: Pre-dose through 8 hours post-dose
SPID
SPID at other times is the time-weighted Summed Pain Intensity Difference over specified time intervals after receiving medication, derived from postoperative dental pain assessed using a 0-10 Numerical Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine". Higher scores indicate a greater level of pain intensity.
Time frame: Pre-dose through Day 7 post-dose
NRS Pain Intensity Scores
NRS is a categorical 0-10 pain rating scale wherein 0 is defined as "no pain" and 10 is the "pain as bad as you can imagine". Higher scores indicate a greater level of pain intensity.
Time frame: Pre-dose through Day 7 post-dose
Median Time to Confirmed Perceptible Pain Relief
Time to confirmed perceptible and meaningful pain relief is measured with the two stopwatch method, with one stopwatch to note first perceptible pain relief and the other stopwatch to note first time to meaningful pain relief.
Time frame: From trial drug administration through 8 hours post-dose
Time to First Use of Rescue Medication
The duration of analgesia generally is defined by the median time to a request for rescue medication. The median time to the first use of rescue medication will be captured from administration of trial medication to first administration of rescue medication.
Time frame: From trial drug administration through 8 hours post-dose
Total Dose of Rescue Medication Consumed
Time frame: From trial drug administration through 8 hours post-dose
Participant Global Assessment at 3, 8 and 24 hours Post-dose
The participant will assess his/her global status of pain relief at designated time periods according to a 5-point categorical scale. The assessment should be based on the following question: "How would you rate the trial drug you were administered for pain relief?" with available Likert (word) scores translated to numerical scores as follows: Poor = 0, Fair = 1, Good = 2, Very Good = 3, or Excellent = 4. Higher scores indicate a greater level of pain relief.
Time frame: At 3, 8, and 24 hours post-dose
Nurse-observer's Assessment of Sedation Score
Nurse-observer's sedation score will be assessed using the Ramsay Sedation Scale (RSS), ranging from 1 to 6, where 1: indicates the participant is anxious, agitated, or restless; 2: indicates the participant is cooperative, oriented, and tranquil; 3: indicates the participant responds to commands only; 4: indicates a brisk response to a light glabellar tap or loud auditory stimulus; 5: indicates a sluggish response to a light glabellar tap or loud auditory stimulus; and 6: indicates no response to these stimuli. Higher scores indicate a greater level of sedation.
Time frame: Pre-dose through 24 hours post-dose
Number of Participants Using Antiemetics During the 8-hour Post-dose Period
Time frame: From trial drug administration through 8 hours post-dose
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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