Healthy VolunteerPhase 1NCT07347223
Safety, Tolerability, and Pharmacokinetics of DD-S052P in Healthy Volunteers
A Phase 1 study testing DD-S052P in people with Healthy Volunteer, run by HLB Science at 1 site in South Korea.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study designed to evaluate the safety, tolerability, and pharmacokinetics of DD-S052P in healthy adult volunteers. The study consists of two parts: a single ascending dose (SAD) part and a multiple ascending dose (MAD) part. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- DD-S052P
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2023to 23 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male/female aged to 18-50 years inclusive at the screening visit
- Must agree to adhere to the contraception requirements:
- Female must be of non-childbearing potential, defined as meeting at least one of the following:
- hysteroscopic sterilization
- bilateral tubal ligation or bilateral salpingectomy
- hysterectomy
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- bilateral oophorectomy
- be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
- Female of childbearing potential who are sexually active must agree to use at least one highly effective method of contraception starting from the 1 month prior to first administration of the study drug until 4 months post-dosing:
- Hormonal methods: oral, transdermal, systemic, or implantable contraceptives
- Intrauterine devices (IUDs)
- Barrier methods: condoms or diaphragms used with spermicide
- Surgical sterilization of the male partner
- Male must use of condom by the male subject plus an effective method of contraception for the subject partner of childbearing potential from study drug administration until 4 months post-dosing (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm, surgical sterilization, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle)
- Male subjects must not donate sperm from the first dosing until 90 days after the last dosing
- Non-smoker subject or smoker of not more than 5 cigarettes a day
- Body Mass Index (BMI) between 18.5 and 32.0 (kg/m2) inclusive, with body weight between 60 and 100 kg inclusive, at Screening and Day -1
- Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination)
- Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 min in supine position:
- 95 mmHg ≤ Systolic Blood Pressure (SBP) ≤ 140 mmHg,
- 50 mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg,
- 50 bpm ≤ HR ≤ 90 bpm,
- Or considered not clinically significant (NCS) by investigators;
- Normal ECG recording on a 12-lead ECG at the screening visit:
- 120 < PR < 210 ms,
- QRS < 120 ms,
- QTcF ≤ 430 ms for male and QTcF ≤ 450 ms for female
- No sign of any trouble of sinusal automatism,
- Or considered NCS by investigators
- Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non-relevant by the Investigator
- Normal dietary habits
- Signing a written informed consent prior to participation
- Subject with estimated Glomerular Filtration Rate (eGFR) ≥ 80 mL/min/1.73 m2, as estimated using CKD-EPI creatinine Equation (2021)
Who cannot join
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, infectious disease; endocrine, immunologic, dermatologic or/and any relevant disease
- Subject with proteinuria, Grade 2 or higher (CTCAE, Ver.5.0)
- Symptomatic hypotension whatever the decrease of the blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within 2 min of changing from supine to standing position
- Positive urine drug testing or alcohol testing at Screening or Day -1
- Positive Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests
- Clinical symptoms suspected of acute infectious disease within 2 weeks before the first study drug administration
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- Any medication intake (except acetaminophen) within 1 month or within 5 times the elimination half-life of the medication (whichever is longer) prior to the first administration of study drug
- Serious or severe adverse reaction, including hypersensitivity, anaphylaxis or hepatotoxicity to carbapenems, cephalosporins, penicillins, polyethylene glycol derivatives, monobactams or any other medication
- History of hypersensitivity to Ringer solution
- Blood donation (including as part of a clinical trial) within 2 months before administration
- General anaesthesia within 3 months before administration
- Inability to abstain from intense muscular effort
- Subjects who cannot be reliably contacted in case of an emergency
- Excessive consumption of beverages with xanthine bases (> 4 cups or glasses/day)
- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development
- Persons deprived of their liberty by judicial or administrative decision; persons under coercive psychiatric care; adults under legal protection (guardianship/trusteeship); persons under court protection
- Participation in any interventional study within 60 days or within 5 times the elimination half-life of the interventional study drug (whichever is longer) before study check-in
- Pregnant or breastfeeding or intended to become pregnant during the study
- Any other reasons identified by the investigator that would preclude the subject's participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DD-S052P in Healthy Volunteers
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study designed to evaluate the safety, tolerability, and pharmacokinetics of DD-S052P in healthy adult volunteers.
The study consists of two parts: a single ascending dose (SAD) part and a multiple ascending dose (MAD) part. In the SAD part, participants will receive a single intravenous infusion of DD-S052P or placebo at increasing dose levels. In the MAD part, participants will receive multiple intravenous infusions of DD-S052P or placebo over several days.
Read more
Safety and tolerability will be assessed through monitoring of adverse events, vital signs, physical examinations, electrocardiograms (ECGs), and clinical laboratory tests. Pharmacokinetic assessments will be performed to characterize plasma concentrations of DD-S052P over time following single and multiple dosing.
The results of this study will provide important information to support further clinical development of DD-S052P.
Read the detailed description
This Phase 1 study is a randomized, double-blind, placebo-controlled, first-in-human clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of DD-S052P following intravenous administration in healthy adult subjects.
The study consists of two sequential parts: a single ascending dose (SAD) part and a multiple ascending dose (MAD) part.
In the SAD part, cohorts of healthy subjects will receive a single intravenous infusion of DD-S052P or placebo at escalating dose levels. Dose escalation to the next cohort will occur only after a review of available safety and tolerability data from the preceding cohort, in accordance with predefined stopping and escalation criteria.
In the MAD part, healthy subjects will receive multiple intravenous doses of DD-S052P or placebo administered once daily over consecutive days. Dose levels for the MAD part will be selected based on the safety, tolerability, and pharmacokinetic results obtained from the SAD part.
Safety and tolerability will be evaluated throughout the study by monitoring adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination findings, electrocardiograms (ECGs), and clinical laboratory parameters.
Pharmacokinetic assessments will be conducted to characterize plasma concentration-time profiles of DD-S052P following single and multiple dosing. Key pharmacokinetic parameters will be derived using standard non-compartmental methods, as appropriate.
The results of this study will provide essential information on the safety profile and pharmacokinetic characteristics of DD-S052P and will support further clinical development.
- Conditions
- Healthy Volunteer
- Being tested
- DD-S052P, Placebo
- Keywords
- DD-S052P, Phase 1, First-in-Human, Healthy Volunteers, Single Ascending Dose, Intravenous Administration, Safety, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DD-S052PDrug
DD-S052P is administered as an intravenous infusion at single or multiple ascending dose levels to evaluate safety, tolerability, and pharmacokinetics in healthy adult subjects.
PlaceboDrug
Placebo solution administered as an intravenous infusion, matching the investigational product in appearance, volume, and administration schedule.
| Study group | Role | What they receive |
|---|---|---|
| DD-S052P (SAD/MAD) | Experimental | Participants receive DD-S052P administered as an intravenous infusion over 4 hours. Single ascending doses (SAD) or multiple ascending doses (MAD) are evaluated to assess safety, tolerability, and pharmacokinetics in healthy volunteers. Receives: Drug: DD-S052P |
| Placebo (SAD/MAD) | Placebo comparator | Participants receive placebo (Ringer solution) administered as an intravenous infusion over 4 hours, matching the dosing schedule of the DD-S052P treatment in the single and multiple ascending dose cohorts. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Safety and tolerability will be evaluated by summarizing the number of participants experiencing one or more treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) following administration of DD-S052P.
Adverse events will be assessed by the Investigator for severity and relationship to study drug. Severity grading will follow CTCAE v5.0, where applicable.
Measured: From first study drug administration through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).
Change From Baseline in Vital Signs
Change from baseline will be assessed for the following vital sign parameters:
systolic blood pressure (mmHg), diastolic blood pressure (mmHg), heart rate (beats per minute), oral body temperature (°C), oxygen saturation (SpO₂, %), and respiratory rate (breaths per minute).
Measured: From baseline (pre-dose) through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters
Change from baseline will be assessed for the following 12-lead ECG parameters:
QT interval corrected using Fridericia's formula (QTcF, ms), PR interval (ms), and QRS duration (ms).
Measured: From baseline (pre-dose) through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).
Number of Participants With Clinically Significant Abnormal Laboratory Results
Clinically significant abnormal laboratory findings will be summarized as the number of participants with one or more abnormal laboratory results, as assessed by the Investigator.
Laboratory assessments include hematology, serum chemistry/biochemistry, coagulation parameters, thyroid function tests, and urinalysis.
Measured: From baseline through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start24 Jul 2023
- Primary completion23 May 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to receive either DD-S052P or placebo in parallel cohorts within single ascending dose and multiple ascending dose parts.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- HLB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347223
- Sponsor's protocol ID
- DD-S052P-P1
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DD-S052P in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07347223
- Acronym / sponsor ID
- DD-S052P-P1
- Conditions
- Healthy Volunteer
- Keywords
- DD-S052P, Phase 1, First-in-Human, Healthy Volunteers, Single Ascending Dose, Intravenous Administration, Safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- HLB ScienceIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study designed to evaluate the safety, tolerability, and pharmacokinetics of DD-S052P in healthy adult volunteers.
The study consists of two parts: a single ascending dose (SAD) part and a multiple ascending dose (MAD) part. In the SAD part, participants will receive a single intravenous infusion of DD-S052P or placebo at increasing dose levels. In the MAD part, participants will receive multiple intravenous infusions of DD-S052P or placebo over several days.
Safety and tolerability will be assessed through monitoring of adverse events, vital signs, physical examinations, electrocardiograms (ECGs), and clinical laboratory tests. Pharmacokinetic assessments will be performed to characterize plasma concentrations of DD-S052P over time following single and multiple dosing.
The results of this study will provide important information to support further clinical development of DD-S052P.
Detailed description
This Phase 1 study is a randomized, double-blind, placebo-controlled, first-in-human clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of DD-S052P following intravenous administration in healthy adult subjects.
The study consists of two sequential parts: a single ascending dose (SAD) part and a multiple ascending dose (MAD) part.
In the SAD part, cohorts of healthy subjects will receive a single intravenous infusion of DD-S052P or placebo at escalating dose levels. Dose escalation to the next cohort will occur only after a review of available safety and tolerability data from the preceding cohort, in accordance with predefined stopping and escalation criteria.
In the MAD part, healthy subjects will receive multiple intravenous doses of DD-S052P or placebo administered once daily over consecutive days. Dose levels for the MAD part will be selected based on the safety, tolerability, and pharmacokinetic results obtained from the SAD part.
Safety and tolerability will be evaluated throughout the study by monitoring adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination findings, electrocardiograms (ECGs), and clinical laboratory parameters.
Pharmacokinetic assessments will be conducted to characterize plasma concentration-time profiles of DD-S052P following single and multiple dosing. Key pharmacokinetic parameters will be derived using standard non-compartmental methods, as appropriate.
The results of this study will provide essential information on the safety profile and pharmacokinetic characteristics of DD-S052P and will support further clinical development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Participants are assigned to receive either DD-S052P or placebo in parallel cohorts within single ascending dose and multiple ascending dose parts.
| Arm | Type | Receives |
|---|---|---|
| DD-S052P (SAD/MAD) | Experimental | Drug: DD-S052PParticipants receive DD-S052P administered as an intravenous infusion over 4 hours. Single ascending doses (SAD) or multiple ascending doses (MAD) are evaluated to assess safety, tolerability, and pharmacokinetics in healthy volunteers. |
| Placebo (SAD/MAD) | Placebo comparator | Drug: PlaceboParticipants receive placebo (Ringer solution) administered as an intravenous infusion over 4 hours, matching the dosing schedule of the DD-S052P treatment in the single and multiple ascending dose cohorts. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (33 listed)
- Healthy male/female aged to 18-50 years inclusive at the screening visit
- Must agree to adhere to the contraception requirements:
- Male subjects must not donate sperm from the first dosing until 90 days after the last dosing
- Non-smoker subject or smoker of not more than 5 cigarettes a day
- Body Mass Index (BMI) between 18.5 and 32.0 (kg/m2) inclusive, with body weight between 60 and 100 kg inclusive, at Screening and Day -1
Key exclusion criteria (19 listed)
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, infectious disease; endocrine, immunologic, dermatologic or/and any relevant disease
- Subject with proteinuria, Grade 2 or higher (CTCAE, Ver.5.0)
- Symptomatic hypotension whatever the decrease of the blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within 2 min of changing from supine to standing position
- Positive urine drug testing or alcohol testing at Screening or Day -1
- Positive Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DD-S052PDD-S052P is administered as an intravenous infusion at single or multiple ascending dose levels to evaluate safety, tolerability, and pharmacokinetics in healthy adult subjects. | Drug | DD-S052P (SAD/MAD) |
| PlaceboPlacebo solution administered as an intravenous infusion, matching the investigational product in appearance, volume, and administration schedule. | Drug | Placebo (SAD/MAD) |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From first study drug administration through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).
Safety and tolerability will be evaluated by summarizing the number of participants experiencing one or more treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) following administration of DD-S052P. Adverse events will be assessed by the Investigator for severity and relationship to study drug. Severity grading will follow CTCAE v5.0, where applicable.
Change From Baseline in Vital Signs
Time frame: From baseline (pre-dose) through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).
Change from baseline will be assessed for the following vital sign parameters: systolic blood pressure (mmHg), diastolic blood pressure (mmHg), heart rate (beats per minute), oral body temperature (°C), oxygen saturation (SpO₂, %), and respiratory rate (breaths per minute).
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters
Time frame: From baseline (pre-dose) through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).
Change from baseline will be assessed for the following 12-lead ECG parameters: QT interval corrected using Fridericia's formula (QTcF, ms), PR interval (ms), and QRS duration (ms).
Number of Participants With Clinically Significant Abnormal Laboratory Results
Time frame: From baseline through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).
Clinically significant abnormal laboratory findings will be summarized as the number of participants with one or more abnormal laboratory results, as assessed by the Investigator. Laboratory assessments include hematology, serum chemistry/biochemistry, coagulation parameters, thyroid function tests, and urinalysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DD-S052P in people with Healthy Volunteer, run by HLB Science at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: From first study drug administration through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.