Safety Evaluation in Healthy Colombian Volunteers of P2Et Extract Obtained from Caesalpinia spinosa: Design 3+3 Phase I Clinical Trial

Table 6

Immunophenotype in healthy volunteers in baseline, final visit, and percentage of change.

	Extract P2Et 600 mg/d			Normal range 1
	Baseline visit	Final visit	% change
T lymphocyte cells
CD3^+/CD5^+/CD45^+ (%)	21.9 [16.1, 29.6]	22.6 [20.2, 29.6]	23.9 [−7.79, 40.4]	55–74
CD3^+/CD5^+/CD45^+ (cel/μl)	1120 [1030, 1690]	1150 [1060, 1530]	7.50 [−33.6, 31.6]	850–1850
CD3^+/CD4^+ (%)	11.0 [10.0, 12.8]	13.2 [12.0, 15.0]	27.0 [−3.91, 32.0]	27–41
CD3^+/CD4^+ (cel/μl)	613 [545, 795]	643 [530, 943]	16.5 [−19.2, 25.7]	440–960
CD3^+/CD8^+ (%)	9.10 [4.50, 17.1]	9.00 [6.00, 14.4]	29.3 [−15.8, 54.0]	18–34
CD3^+/CD8^+ (cel/μl)	432 [310, 974]	482 [374, 651]	−1.63 [−44.0, 41.6]	300–820
CD4^+/CD8^+ (%)	0.30 [0.10, 1.50]	0.20 [0.10, 1.00]	40.0 [−33.3, 100]
CD4^+/CD8^+ (cel/μl)	17.0 [5.00, 69.0]	11.0 [5.00, 66.0]	25.0 [−52.9, 83.3]
CD4−/CD8− (%)	1.00 [0.30, 1.60]	1.10 [0.30, 2.20]	33.3 [−25.0, 71.4]
CD4−/CD8− (cel/μl)	60.0 [20.0, 88.0]	52.0 [16.0, 117]	−8.75 [−44.1, 60.
CD4/CD8 relation	1.25 [0.600, 2.40]	1.30 [1.00, 2.20]	−4.17 [−15.0, 66.7]	1–3.6
NK cells
CD3−/CD56^+/CD45^+ (%)	2.10 [1.50, 9.90]	3.00 [1.30, 5.80]	0.00 [−55.6, 63.6]	F: 2.5–26.7
				M: 4–46.6
CD3−/CD56^+/CD45^+ (cel/μl)	137 [82.9, 541]	177 [61.3, 236]	−5.88 [−59.5, 114]	F: 44.9–552.7
				M: 78.1–974.1
B lymphocyte cells
CD19^+/CD20/CD38^+/CD45^+ (%)	2.80 [1.90, 6.40]	2.60 [2.10, 10.0]	18.4 [−40.5, 56.3]	6–19
CD19^+/CD20/CD38^+/CD45^+(cel/μl)	172 [105, 302]	165 [83.2, 443]	10.4 [−60.5, 47.1]	100–500
sLambda^+ (%)	1.20 [1.00, 2.40]	1.20 [0.90, 3.80]	20.0 [−44.4, 58.3]
sLambda^+ (cel/μl)	75.7 [55.3, 119]	67.9 [35.8, 168]	6.21 [−65.1, 49.1]
sKappa^+ (%)	1.60 [0.90, 4.00]	1.50 [1.10, 6.20]	13.0 [−36.8, 55.0]
sKappa^+ (cel/μl)	96.4 [49.7, 188]	97.1 [45.4, 274]	7.44 [−58.0, 46.0]
Granulocytes CD45^+ (%)	63.2 [48.5, 69.8]	59.7 [48.3, 65.2]	−9.97 [−19.5, 9.93]	45–70
Granulocytes CD45^+ (cel/μl)	2970 [2760, 5560]	3070 [1830, 4500]	−13.1 [−49.0, 15.3	2100–6100
Monocytes CD45^+/CD38^+/CD4^+ (%)	6.10 [3.40, 7.80]	6.00 [3.70, 8.80]	−5.71 [−25.6, 76.5]	0–10
Monocytes CD45^+/CD38^+/CD4^+(cel/μl)	358 [160, 549]	273 [262, 428]	−19.2 [−23.9, 66.2]	300–900
Eosinophils CD45^+ (%)	1.60 [0.500, 3.90]	1.50 [0.800, 7.60]	4.35 [−50.0, 140]	0–7
Eosinophils CD45^+ (cel/μl)	88.4 [39.8, 268]	66.4 [37.7, 556]	10.3 [−48.8, 107]	0–500
Basophils CD45^+/CD38^+ (%)	0.750 [0.400, 1.30]	0.700 [0.100, 0.800]	−6.25 [−38.5, 50.0]	0–1
Basophils CD45^+/CD38^+ (cel/μl)	36.7 [18.8, 89.5]	32.9 [4.80, 58.5]	−5.52 [−34.6, 17.6]	0–200
Dendritic cells
Derived monocytes
CD45^++/CD38^+/CD4^+ (%)	0.300 [0.100, 1.00]	0.650 [0.200, 2.60]	66.7 [−33.3, 500]	0–1
CD45^++/CD38^+/CD4^+ (cel/μl)	13.8 [4.70, 51.2]	38.0 [8.80, 98.4]	34.4 [−31.9, 535]	0–200

Data are in median [minimum, maximum] range; (n = 7). W: female; M: male.